Laparoscopic colposuspension for urinary incontinence in women
Abstract
Background
Laparoscopic colposuspension was one of the first minimal access operations for treating stress urinary incontinence in women, with the presumed advantages of shorter hospital stays and quicker return to normal activities.
This Cochrane Review was last updated in 2010.
Objectives
To assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions.
Search methods
We searched the Cochrane Incontinence Specialised Register (22 May 2019), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings.
Selection criteria
Randomised controlled trials of women with urinary incontinence that included laparoscopic surgery in at least one arm.
Data collection and analysis
We independently extracted data from eligible trials, assessed risk of bias and implemented GRADE.
Main results
We included 26 trials involving 2271 women.
Thirteen trials (1304 women) compared laparoscopic colposuspension to open colposuspension and nine trials (412 women) to midurethral sling procedures. One trial (161 women) compared laparoscopic colposuspension with one suture to laparoscopic colposuspension with two sutures; and three trials (261 women) compared laparoscopic colposuspension with sutures to laparoscopic colposuspension with mesh and staples. The majority of trials did not follow up participants beyond 18 months. Overall, there was unclear risk of selection, performance and detection bias and generally low risk of attrition and reporting bias.
There is little difference between laparoscopic colposuspension using sutures and open colposuspension for subjective cure within 18 months (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.99 to 1.08; 6 trials, 755 women; high‐quality evidence). We are uncertain whether laparoscopic colposuspension using mesh and staples is better or worse than open colposuspension for subjective cure within 18 months (RR 0.75, 95% CI 0.61 to 0.93; 3 trials, 362 women; very low‐quality evidence) or whether there is a greater risk of repeat continence surgery with laparoscopic colposuspension. Laparoscopic colposuspension may have a lower risk of perioperative complications (RR 0.67, 95% CI 0.47 to 0.94; 11 trials, 1369 women; low‐quality evidence). There may be similar or higher rates of bladder perforations with laparoscopic colposuspension (RR 1.72, 95% CI 0.90 to 3.29; 10 trials, 1311 women; moderate‐quality evidence). Rates for de novo detrusor overactivity (RR 1.29, 95% CI 0.72 to 2.30; 5 trials, 472 women) and voiding dysfunction (RR 0.81, 95% CI 0.50 to 1.31; 5 trials, 507 women) may be similar but we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data.
There may be little difference between laparoscopic colposuspension using sutures and tension‐free vaginal tape (TVT) for subjective cure within 18 months (RR 1.01, 95% CI 0.88 to 1.16; 4 trials, 256 women; low‐quality evidence) or between laparoscopic colposuspension using mesh and staples and TVT (RR 0.71, 95% CI 0.55 to 0.91; 1 trial, 121 women; low‐quality evidence). For laparoscopic colposuspension compared with midurethral slings, there may be lower rates of repeat continence surgery (RR 0.40, 95% CI 0.04 to 3.62; 1 trial, 70 women; low‐quality evidence) and similar risk of perioperative complications (RR 0.99, 95% CI 0.60 to 1.64; 7 trials, 514 women; low‐quality evidence) but we are uncertain due to the wide confidence intervals. There may be little difference in terms of de novo detrusor overactivity (RR 0.80, 95% CI 0.34 to 1.88; 4 trials, 326 women; low‐quality evidence); and probably little difference in terms of voiding dysfunction (RR 1.06, 95% CI 0.47 to 2.41; 5 trials, 412 women; moderate‐quality evidence) although we are uncertain due to the wide confidence interval. Five studies reported on quality of life but we could not synthesise the data. No studies reported on bladder perforations.
Low‐quality evidence indicates that there may be higher subjective cure rates within 18 months with two sutures compared to one suture (RR 1.37, 95% CI 1.14 to 1.64; 1 trial, 158 women). Comparing one suture and two sutures, one suture may have lower rates of repeat continence surgery (RR 0.35, 95% CI 0.01 to 8.37; 1 trial, 157 women) and similar risk of perioperative complications (RR 0.88, 95% CI 0.45 to 1.70) but we are uncertain due to the wide 95% CIs. There may be higher rates of voiding dysfunction with one suture compared to two sutures (RR 2.82; 95% CI 0.30 to 26.54; 1 trial, 158 women; low‐quality evidence), but we are uncertain due to the wide confidence interval. This trial did not report bladder perforations, de novo detrusor overactivity or quality of life.
We are uncertain whether laparoscopic colposuspension with sutures is better or worse for subjective cure within 18 months compared to mesh and staples (RR 1.24, 95% CI 0.96 to 1.59; 2 trials, 180 women; very low‐quality evidence) or in terms of repeat continence surgery (RR 0.97, 95% CI 0.06 to 14.91; 1 trial, 69 women; very low‐quality evidence). Laparoscopic colposuspension with sutures may increase the number of perioperative complications compared to mesh and staples (RR 1.94, 95% CI 1.09 to 3.48; 3 trials, 260 women; low‐quality evidence) but rates of de novo detrusor overactivity may be similar (RR 0.72, 95% CI 0.17 to 3.06; 2 trials, 122 women; low‐quality evidence), however, we are uncertain due to the wide confidence interval. None of the studies reported bladder perforations, voiding dysfunction or quality of life.
Authors' conclusions
The data indicate that, in terms of subjective cure of incontinence within 18 months, there is probably little difference between laparoscopic colposuspension and open colposuspension, or between laparoscopic colposuspension and midurethral sling procedures. Much of the evidence is low quality, meaning that a considerable degree of uncertainty remains about laparoscopic colposuspension. Future trials should recruit adequate numbers, conduct long‐term follow‐up and measure clinically important outcomes.
A brief economic commentary identified three studies. We have not quality‐assessed them and they should be interpreted in light of the findings on clinical effectiveness.
PICOs
Plain language summary
Keyhole (laparoscopic) surgery through the abdomen for treating urinary incontinence in women
Review question
We investigated whether keyhole surgery (laparoscopic colposuspension) was better than other types of surgery to treat urinary incontinence (leakage of urine) in women. We also compared different methods of laparoscopic colposuspension to each other.
Background
Urinary incontinence is a common debilitating problem for many women. Around a third of women of child‐bearing age leak urine during physical exertion or when they cough, laugh or sneeze. When urinary incontinence persists after non‐surgical treatment, surgery is often recommended. Laparoscopic colposuspension is an operation carried out through a small incision in the abdomen to hold and support the tissues around the neck of the bladder.
How up‐to‐date is this review?
The evidence is current up to 22 May 2019.
Study characteristics
We identified 26 trials with 2271 women that either compared laparoscopic colposuspension with other types of surgery for managing urinary incontinence or compared different approaches of laparoscopic colposuspension. All the trials followed up the women for at least 18 months after surgery, with some trials lasting around five years. We looked at the robustness of each trial’s methods and the number of women involved to judge the quality of the evidence they presented.
Key results
High‐quality evidence means that we are confident that laparoscopic colposuspension with sutures (keyhole surgery with stitches) is as effective as open colposuspension (traditional surgery) for curing incontinence in the short term (up to 18 months after surgery). However, we are not sure whether there are fewer risks of complications during and after surgery with laparoscopic or open colposuspension.
Procedures using a midurethral sling (a sort of hammock that supports the neck of the bladder) may be as effective as laparoscopic colposuspension in curing urinary incontinence in the short term and avoiding surgical complications. Women may be less likely to need repeat surgery with a ‘sling’ than with laparoscopic colposuspension. We are not sure about these results because the evidence was low quality.
Laparoscopic colposuspension with two sutures may be better than with one suture for curing urinary incontinence in the short term, and for reducing the risk of voiding dysfunction and the need for more surgery, but there may be little difference between laparoscopic colposuspension with two sutures or with one in terms of surgical complications. Again, we are not sure about these results because the evidence was low quality.
We are very uncertain whether laparoscopic colposuspension with mesh and staples is better than open colposuspension or laparoscopic colposuspension with sutures for curing urinary incontinence. We are also very uncertain whether women who have laparoscopic colposuspension with mesh and staples or with sutures need less repeat surgery. We are very uncertain about the results because the quality of evidence was very low.
The evidence that we found relating to the effect of laparoscopic colposuspension on quality of life was inconclusive and could not be generalised.
Quality of the evidence
In general, the quality of the evidence was low. This means that we cannot be certain about the overall effectiveness of laparoscopic colposuspension compared to other treatments for urinary incontinence due to low numbers of women participating in the trials, risk of bias, and differences between trials in the statistical results.
Authors' conclusions
Summary of findings
| Laparoscopic colposuspension compared to open colposuspension for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with open colposuspension | Risk with laparoscopic colposuspension | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using sutures | Study population | RR 1.04 | 755 | ⊕⊕⊕⊕ | ||
| 789 per 1000 | 821 per 1000 | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using mesh and staples | Study population | RR 0.75 | 362 | ⊕⊝⊝⊝ | ||
| 906 per 1000 | 679 per 1000 | |||||
| Quality of life | ‐ | ‐ | 742 | ‐ | Trials collected QoL evidence using a range of validated questionnaires. Data were unsuitable for synthesis and indicated little evidence of a difference between the groups. | |
| Repeat continence surgery: | 60 | At 5 years 3/30 in the laparoscopic colposuspension group and 0/30 in the open colposuspension group had repeat continence surgery. | ||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 0.67 | 1369 | ⊕⊕⊝⊝ | ||
| 174 per 1000 | 117 per 1000 | |||||
| Adverse effects: bladder perforations | Study population | RR 1.72 | 1311 | ⊕⊕⊕⊝ | ||
| 18 per 1000 | 30 per 1000 | |||||
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) | Study population | RR 1.29 | 472 | ⊕⊕⊕⊝ | ||
| 75 per 1000 | 96 per 1000 | |||||
| Adverse effects: voiding dysfunction | Study population | RR 0.81 | 507 | ⊕⊕⊕⊝ | ||
| 109 per 1000 | 88 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to unclear risk of selection bias. | ||||||
| Laparoscopic colposuspension compared to midurethral sling procedures for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with midurethral sling procedures | Risk with laparoscopic colposuspension | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using sutures versus TVT | Study population | RR 1.01 | 256 | ⊕⊕⊝⊝ | ||
| 741 per 1000 | 748 per 1000 | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using mesh versus TVT | Study population | RR 0.71 | 121 | ⊕⊕⊝⊝ | ||
| 829 per 1000 | 588 per 1000 | |||||
| Quality of life | ‐ | ‐ | 385 | ‐ | Trials collected QoL evidence using a range of validated questionnaires. Data were unsuitable for synthesis and indicated little evidence of a difference between the groups. | |
| Repeat continence surgery: | 1/32 women in the laparoscopic colposuspension group and 3/38 women in the midurethral slings group had repeat continence surgery. | RR 0.40 | 70 | ⊕⊕⊝⊝ | ||
| 79 per 1000 | 32 per 1000 | |||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 0.99 | 514 | ⊕⊕⊝⊝ | ||
| 99 per 1000 | 98 per 1000 | |||||
| Adverse effects: bladder perforations | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported. |
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) | Study population | RR 0.80 | 326 | ⊕⊕⊝⊝ | ||
| 62 per 1000 | 50 per 1000 | |||||
| Adverse effects: voiding dysfunction | Study population | RR 1.06 | 412 | ⊕⊕⊕⊝ | ||
| 41 per 1000 | 44 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to unclear risk of bias in most domains. | ||||||
| Laparoscopic colposuspension with one suture compared to laparoscopic colposuspension with two sutures for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with laparoscopic colposuspension with two sutures | Risk with laparoscopic colposuspension with one suture | |||||
| Subjective cure within 18 months | Study population | RR 1.37 | 158 | ⊕⊕⊝⊝ | ||
| 889 per 1000 | 1000 per 1000 | |||||
| Quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Repeat continence surgery: | 1/80 women in the two‐suture group and 0/77 women in the one‐suture group had repeat continence surgery. | RR 0.35 | 157 | ⊕⊕⊝⊝ | ||
| 13 per 1000 | 4 per 1000 | |||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 0.88 | 161 | ⊕⊕⊝⊝ | ||
| 169 per 1000 | 148 per 1000 | |||||
| Adverse effects: bladder perforations | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) Follow‐up: 18 months | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Adverse effects: voiding dysfunction | Study population | RR 2.82 | 158 | ⊕⊕⊝⊝ | ||
| 37 per 1000 | 104 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to serious imprecision: one single small trial and wide CIs indicating possibility of benefit or harm in either direction. | ||||||
| Laparoscopic colposuspension with sutures compared to laparoscopic colposuspension with mesh and staples for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with laparoscopic colposuspension with mesh and staples | Risk with laparoscopic colposuspension with sutures | |||||
| Subjective cure within 18 months | Study population | RR 1.24 | 180 | ⊕⊝⊝⊝ | ||
| 696 per 1000 | 863 per 1000 | |||||
| Quality of life | ‐ | ‐ | ‐ | Not reported | ||
| Repeat continence surgery: follow‐up 1 year | 1/35 in the sutures group and 1/34 in the mesh group had repeat continence surgery. | RR 0.97 | 69 | ⊕⊝⊝⊝ | ||
| 29 per 1000 | 29 per 1000 | |||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 1.94 | 260 | ⊕⊕⊝⊝ | ||
| 114 per 1000 | 221 per 1000 | |||||
| Adverse effects: bladder perforations | ‐ | ‐ | ‐ | ‐ | ‐ | In two trials (Ankardal 2005; Ross 1996), there were more (2 and 4, respectively) bladder perforations in the suture group than in the mesh group (1 perforation). In one trial (Zullo 2001), there was one in each of the groups. |
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) | Study population | RR 0.72 | 122 | ⊕⊕⊝⊝ | ||
| 67 per 1000 | 48 per 1000 | |||||
| Adverse effects: voiding dysfunction | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to unclear risk of selection, performance and detection bias. | ||||||
Background
Description of the condition
Urinary incontinence (UI) is a common and often debilitating problem for many adult women. It is classified into different types. Stress urinary incontinence (SUI) is defined by the involuntary loss of urine associated with physical exertion and activities that increase intra‐abdominal pressure. The International Continence Society and International Urogynaecological Association define urodynamic stress incontinence (USI) as the involuntary leakage of urine during increased abdominal pressure in the absence of a detrusor contraction, noted during filling cystometry (Haylen 2010). Therefore, diagnosis based on this definition requires urodynamic investigation. Urgency urinary incontinence (UUI) is defined as involuntary loss of urine accompanied by or immediately preceded by urgency. Detrusor overactivity (DO) is a diagnosis of involuntary detrusor muscle contractions that are not due to neurological disorders; the diagnosis must be made using urodynamic investigations (Haylen 2010). Mixed urinary incontinence (MUI) is the complaint of involuntary leakage associated both with urgency and with exertion, effort, sneezing or coughing (Abrams 2013). It is thought that urinary incontinence could be due to laxity of the supporting ligament of the pelvis as a result of altered connective tissue (Papa Petros 2010).
Prevalence estimates vary widely (Botlero 2008), but evidence suggests that 25% to 45% of adult women are affected by urinary incontinence and that 3% to 25% of women have some degree of stress incontinence, with older women more likely to be affected (Abrams 2013). Additionally, a survey published in the British Journal of Obstetrics and Gynaecology demonstrated that up to a third of women of child‐bearing age are incontinent during physical exertion or when they cough (Wilson 1996). A longitudinal study of 3763 women showed a prevalence of 37.9% of persistent urinary incontinence 12 years after birth. Compared with having vaginal delivery, women who delivered exclusively by Caesarean section were less likely to have persistent urinary incontinence. However, this was not the case in women who had a combination of Caesarean section and vaginal birth (MacArthur 2016).
Stress urinary incontinence constitutes a huge financial economic burden to society. In the USA, the annual total direct costs of urinary incontinence in both men and women is over USD 16 billion (1995 USD; Chong 2011), with societal costs of USD 26.2 billion (1995 USD; Wagner 1998). Approximately, USD 13.12 billion (1995 USD) of the total direct costs of urinary incontinence is spent on SUI (Chong 2011; Kunkle 2015). About 70% of this USD 13.12 billion is borne by people with SUI, mainly through routine care (purchasing pads and disposable underwear (diapers), laundry and dry cleaning). This constitutes a significant individual financial burden. Of the remaining 30% of costs, 14% is spent on nursing home admission, 9% on treatment, 6% on addressing complications and 1% on diagnosis (Chong 2011).
A study in the USA reported that approximately 1% of the median annual household income (USD 50,000 to USD 59,999 in 2006) was spent by women on incontinence management. This study estimated that women spent an annual mean amount of USD 751 to USD 1277 (2006 USD) on incontinence. This cost increases with the severity of the symptoms (Subak 2008). The indirect cost associated with SUI exerts a social and psychological burden that is unquantifiable (Chong 2011; Kilonzo 2004). Nevertheless, Birnbaum 2004 estimated that the annual average direct medical costs of SUI for one year (1998 USD) was USD 5642 and USD 4208 for indirect workplace costs. The cost of management and treatment of SUI appears to have increased over time due to increasing prevalence and an increased desire for improved quality of life. This, in turn, has resulted from improved recognition of the condition, as well as increased use of surgical and non‐surgical managements. Guidelines developers usually recommend that surgery for UI is only considered, by women and their healthcare providers, after other non‐invasive or conservative treatments have been tried and failed (NICE 2019).
Description of the intervention
Surgical procedures to remedy stress urinary incontinence generally aim to lift and support the urethro‐vesical junction between the urethra and the bladder and increase bladder outlet resistance. However, there is disagreement regarding the precise mechanism by which continence is achieved after surgery. The choice of procedures is often influenced by co‐existent problems, a surgeon's specialty or preference and the physical features of the person affected. Numerous surgical methods have been described but essentially they fall into seven categories:
-
open abdominal retropubic urethropexy (e.g. colposuspension (Burch), Marshall‐Marchetti‐Krantz; Lapitan 2017);
-
laparoscopic retropubic colposuspension (this review);
-
anterior vaginal repair (anterior colporrhaphy) (e.g. Kelly, Pacey; Glazener 2017a);
-
midurethral/suburethral slings (traditional retropubic tension‐free vaginal tape (TVT; Ford 2017), transobturator tape (TOT; Rehman 2017); and single incision slings (Nambiar 2017));
-
needle suspensions (e.g. Pereyra, Stamey; Glazener 2017b);
-
periurethral injections (Kirchin 2017); and
-
artificial sphincters.
How the intervention might work
Laparoscopic incontinence procedures were first introduced in the early 1990s, with the advantage to patients that they avoided the major incisions of conventional open surgery (Vancaillie 1991). It was claimed that this would result in shorter lengths of hospital stay and shorten the time to return to normal activities.
The most popular laparoscopic procedure for urinary incontinence is laparoscopic colposuspension. As in open colposuspension, sutures are inserted into the vaginal tissues on either side of the neck of the bladder; these are then attached to a ligament on the inside of the pelvic bone called the ileopectineal ligaments on each side respectively. There are, however, technical variations in how the laparoscopic approach is carried out. This would include a variation in the number and type of sutures used and where these are anchored or attached, the use of mesh and staples as an alternative to sutures and whether the laparoscopic approach is carried out transperitoneal (when the laparoscope is inserted into the abdominal cavity) or extraperitoneal (when the laparoscope not inserted into the abdominal cavity) (Abrams 2013; Jarvis 1999).
Why it is important to do this review
Treatment for stress incontinence includes conservative, pharmacological and surgical therapies. This review is one of a series of inter‐related Cochrane Reviews of surgical approaches for the management of urinary incontinence. These include: Ford 2017; Glazener 2017a; Glazener 2017b; Kang 2015; Kirchin 2017; and Rehman 2017.
In the current context of controversies surrounding the safety of incontinence surgery using mesh, colposuspension has been revived as a preferred treatment option. It is therefore important to revisit the evidence base for this intervention to enable women and clinicians to make informed treatment decisions. In addition, the review also summarises published evidence for both the impacts of the interventions on resource use (costs) and for their comparative efficiency (cost‐effectiveness).
Objectives
To assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions.
Methods
Criteria for considering studies for this review
Types of studies
We included randomised controlled trials (RCTs) or quasi‐RCTs of women with stress or mixed urinary incontinence that included laparoscopic colposuspension in at least one arm.
Types of participants
We included studies of adult women with urinary incontinence who were diagnosed with one or more of the following:
-
urodynamic stress incontinence (urodynamic diagnosis)
-
stress incontinence (clinical diagnosis)
-
mixed incontinence (stress incontinence plus other urinary symptoms such as urgency incontinence)
The definitions we used for the above diagnoses were those used by the authors of the trial reports.
Types of interventions
At least one arm of a study must have involved laparoscopic colposuspension to treat urinary incontinence.
We made the following nine comparisons.
-
Laparoscopic colposuspension versus no treatment or sham operation
-
Laparoscopic colposuspension versus conservative interventions (e.g. pelvic floor muscle training, electrical stimulation, cones, biofeedback)
-
Laparoscopic colposuspension versus open colposuspension (abdominal surgery)
-
Laparoscopic colposuspension versus traditional sling procedures (abdominal and vaginal surgery)
-
Laparoscopic colposuspension versus midurethral sling procedures (abdominal and vaginal surgery)
-
Laparoscopic colposuspension versus needle suspension (abdominal and vaginal surgery)
-
Laparoscopic colposuspension versus anterior vaginal repair
-
Laparoscopic colposuspension versus periurethral injections
-
One method of laparoscopic colposuspension versus another
Types of outcome measures
We selected outcome measures used in this review on the basis of their relevance to the clinical cure or improvement of incontinence. As such, we adopted the recommendations made by the Standardisation Committee of the International Continence Society (ICS), which recommends that research looking into the effects of therapeutic interventions for women with urinary incontinence should take into consideration the following outcome domains:
-
patient’s observations with respect to the symptoms of urinary incontinence
-
quantification of patient’s symptoms
-
clinician’s observations (functional and anatomical)
-
patient’s quality of life
-
adverse effects
We have not abstracted urodynamic measurements such as uroflowmetry, post‐void residual, leak point pressure and both abdominal and detrusor pressure in this review as they are surrogate measures of bladder function, with uncertain clinical significance.
Primary outcomes
-
Subjective outcome (women's perception of incontinence cure)
-
Subjective cure of urinary incontinence within 18 months (short‐term)
-
Subjective cure of urinary incontinence after 18 months and within five years (medium‐term)
-
Subjective cure of urinary incontinence after five years (long‐term)
-
Secondary outcomes
-
Women's observations
-
Patient‐reported use of pads, or number of pads used
-
Urgency symptoms (de novo symptoms) or urgency incontinence (clinical diagnosis without urodynamics)
-
-
Quantification of symptoms
-
Number of incontinent episodes (bladder diary)
-
Pad tests of quantified leakage (mean volume or weight of urine loss)
-
-
Objective cure (clinicians' measures)
-
Stress testing (alone or at cystometrogram)
-
Urodynamically‐assessed incontinence (the observation of urinary stress incontinence on filling cystometry in the absence of a detrusor contraction)
-
-
Quality of life
-
Condition‐specific quality‐of‐life measures, for example, Urogenital Distress Inventory (Shumaker 1994), or specific instruments designed to assess incontinence
-
General health status measures, for example, Short Form 36 (Ware 1993)
-
-
Surgical outcome measures
-
Repeat continence surgery
-
Pain or analgesia requirements
-
Length of inpatient stay
-
Time to return to normal activity level
-
Operation time
-
Blood loss
-
Duration of catheterisation
-
-
Adverse effects
-
Perioperative surgical complications, for example, infection, haemorrhage, bladder perforation (number of events)
-
De novo detrusor overactivity (urodynamic diagnosis)
-
Voiding dysfunction
-
Urinary retention
-
Main outcomes for 'Summary of findings' tables
We included the following seven outcomes in 'Summary of findings' tables:
-
Subjective cure; within 18 months
-
Quality of life (condition‐specific assessed with standardised questionnaire, such as the Short Incontinence Impact Questionnaire (SIIQ))
-
Repeat continence surgery
-
Adverse effects: perioperative complications (e.g. pain, bleeding); number of events
-
Adverse effects: bladder perforations
-
Adverse effects: de novo detrusor overactivity
-
Adverse effects: voiding dysfunction
Search methods for identification of studies
We did not impose any language or other limits on the searches.
Electronic searches
Search for clinical effectiveness studies
We drew on the search strategy developed for Cochrane Incontinence. We identified relevant trials from the Cochrane Incontinence Specialised Register. For more details of the search methods used to build the Specialised Register, please see the Group's webpages where details of the Register's development (from inception) and the most recent searches performed to populate the Register can be found. To summarise, the Register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), National Institute for Health Research Be Part of Research (NIHR Be Part of Research) and handsearching of journals and conference proceedings. Many of the trials in the Cochrane Incontinence Specialised Register are also contained in CENTRAL.
The date of the last search was 22 May 2019.
The Cochrane Incontinence Specialised Register was searched using the Group's own keyword system. The search terms we used are given in Appendix 1.
Search for economic evaluations
We also performed supplementary electronic searches designed to identify published reports of relevant economic evaluations to inform the brief economic commentary (BEC) (see 'Incorporating economic evidence' in the Methods). We searched the following databases:
-
MEDLINE on OvidSP (covering 1 January 1946 to week 5 July 2018) searched on 10 August 2018;
-
Embase on OvidSP (covering 1 January 1980 to week 32 2018) searched on 10 August 2018;
-
NHS Economic Evaluation Database (NHS EED) on OvidSP (1st Quarter 2016) searched on 6 April 2017 (this database is no longer updated by the producer).
Appendix 2 contains details of these supplementary electronic searches, including the search terms we used.
Searching other resources
In addition to the aforementioned searches of bibliographic databases, journals and conference proceedings, we checked all reference lists of identified trials and other relevant articles. We also contacted authors and trialists in the field to identify any additional or unpublished data or trials.
Data collection and analysis
Selection of studies
Two review authors independently screened the list of titles and abstracts generated by the search and retrieved full‐text articles of potentially relevant trials, which two review authors independently assessed for eligibility. We resolved any differences of opinion through discussion or by involving a third review author.
Data extraction and management
Two review authors independently extracted data from the included trials using a standardised data extraction form. We resolved any disagreement by discussion or by consulting a third review author. We contacted trial authors where there was insufficient information regarding the outcomes or other relevant aspects of the published reports. We processed data from the included trials according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a).
Assessment of risk of bias in included studies
We assessed the risk of bias in the included trials using the Cochrane 'Risk of bias' tool (Higgins 2017). Two review authors independently assessed the following domains: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; incomplete outcome data; selective reporting; and other bias. We resolved any differences of opinion through consensus or by consulting a third review author.
Measures of treatment effect
We based analyses on available data from all included trials relevant to the comparisons and outcomes of interest. For categorical outcomes, we related the numbers reporting an outcome to the numbers at risk in each group to calculate a risk ratio (RR) with 95% confidence intervals (CI). For continuous variables, we used means and standard deviations (SD) to calculate a mean difference (MD) with 95% CI. Where data required us to calculate RRs or MDs were not given, we utilised the most detailed numerical data available (e.g. test statistics, P values) to calculate the actual numbers or mean and SDs.
Unit of analysis issues
The primary analysis was per woman randomised. Where trials had more than two treatment arms, we analysed each pair of arms as a separate comparison. To avoid double‐counting participants, where a trial with three treatment arms was included in two subgroups in the same meta‐analysis, we divided the number of participants and events by half in the group that was included twice in the meta‐analysis.
Dealing with missing data
We analysed the data on an intention‐to‐treat basis as far as possible. The principles of intention‐to‐treat analysis are that outcome data must be measured on all participants, all randomised participants must be included in the analysis and participants must be retained in the intervention groups to which they were assigned (Higgins 2011b). However, for this review the criterion set for intention‐to‐treat analysis was that participants be retained and analysed in the intervention groups to which they had been assigned. Where this was not the case, we considered whether the trial should be excluded. We made attempts to obtain missing data from the original trialists. However, where this was not possible, we reported data as given in the trials, except where there was evidence of differential loss to follow‐up between the intervention groups. In that case, we considered the use of imputation of missing data.
Where mean values were reported without SDs, we assumed the outcome to have a SD equal to the highest SD from the other trials within the same analysis using the Review Manager 5 (RevMan 5) calculator where feasible (Review Manager 2014).
Assessment of heterogeneity
We only combined trial data if there was no clinical heterogeneity. We investigated differences between trials if significant heterogeneity was found from the Chi² test or the I² statistic (Higgins 2003). We followed the guidance in the Cochrane Handbook for Systematic Reviews of Interventions in order to deal with significant heterogeneity according to interpretations of the I² statistic as follows (Deeks 2017).
-
0% to 40%: might not be important
-
30% to 60%: may represent moderate heterogeneity
-
50% to 90%: may represent substantial heterogeneity
-
75% to 100%: considerable heterogeneity
We assessed heterogeneity between studies by visual inspection of plots of the data, the Chi² test for heterogeneity and the I² statistic (Higgins 2003). We deemed visual heterogeneity positive when the confidence intervals of studies did not overlap. This was then confirmed by formal statistical testing.
Assessment of reporting biases
Had data allowed, we planned to assess the likelihood of potential publication bias using funnel plots, provided that 10 or more eligible trials were identified.
Data synthesis
We combined trials with similar interventions in a meta‐analysis using a fixed‐effect model unless there was evidence of heterogeneity across studies. Where significant heterogeneity existed, we used a random‐effects model.
Subgroup analysis and investigation of heterogeneity
We performed subgroup analyses comparing the variations in surgical techniques within similar surgical procedure subgroups, e.g. laparoscopic colposuspension using sutures or laparoscopic colposuspension using mesh compared with open colposuspension. This latter subgroup analysis was conducted to reflect the recent clinical trend favouring using sutures with laparoscopic colposuspension rather than mesh.
Sensitivity analysis
Had data allowed, we had planned sensitivity analyses comparing trials with low risk of selection bias to those with high risk of selection bias.
'Summary of findings' tables
We used the GRADE system to assess the quality of the body of evidence (Guyatt 2008). This approach uses four categories (very low, low, moderate and high) to rate the quality of evidence available for selected outcomes. As an example, evidence from RCTs starts at a level of high quality but may be downgraded if there are other indications of low quality, such as small sample sizes or high risk of bias. Where we applied such downgrading, we have noted it in footnotes in the 'Summary of findings' tables.
Incorporating economic evidence
Following the search outlined in the Search methods for identification of studies, we developed a brief economic commentary (BEC) to summarise the availability and principal findings of the full economic evaluations that compare laparoscopic colposuspension versus other procedures for treating urinary incontinence in women (Shemilt 2019). This BEC encompasses full economic evaluations (i.e. cost‐effectiveness analyses, cost‐utility‐analyses and cost‐benefit analyses), conducted alongside or based upon one or more RCTs included in the main review of intervention effects (primarily trial‐based economic evaluations), or using a modelling framework (primarily model‐based economic evaluations). This commentary focuses on the extent to which principal findings of eligible economic evaluations indicate that an intervention might be judged favourably or unfavourably from an economic perspective when implemented in different settings.
Results
Description of studies
Results of the search
Search for clinical effectiveness studies
We screened a total of 96 records produced by the literature search and identified 61 reports of 26 included studies. The flow of literature through the assessment process is shown in Figure 1. Seven trials were reported only as abstracts (Adile 2001; Burton 1997; Maher 2004; Mirosh 2005; Morris 2001; Stangel‐Wojcikiewicz 2008; Summitt 2000). Where we required more detailed trial information we contacted the trial authors.
PRISMA study flow diagram: search for effectiveness studies
In total, we included 26 trials in this review (Adile 2001; Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Maher 2004; Mirosh 2005; Morris 2001; Paraiso 2004; Persson 2000; Persson 2002; Ross 1996; Samiee 2009; Stangel‐Wojcikiewicz 2008; Su 1997; Summitt 2000; Tuygun 2006; Ustun 2003; Ustun 2005; Valpas 2004; Wallwiener 1995; Zullo 2001).
Search for economic evaluations
Searches for economic evaluations to inform the development of the brief economic commentary (BEC) produced a total of 465 titles and abstracts to be screened, from which three met the inclusion criteria (Cody 2003; Dumville 2006; Valpas 2006). The flow of literature through the assessment process is shown in Figure 2.
PRISMA study flow diagram: search for economic evaluations for the BEC
Included studies
Of the 26 included trials, thirteen (1396 women) involved the comparison of laparoscopic with open colposuspension (Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Morris 2001; Stangel‐Wojcikiewicz 2008; Su 1997; Summitt 2000; Tuygun 2006; Ustun 2005). Nine (412 women) compared laparoscopic colposuspension with midurethral vaginal tapes; seven with retropubic TVT, one with SPARC and one with TOT approach (Adile 2001; Foote 2006; Maher 2004; Mirosh 2005; Paraiso 2004; Persson 2002; Samiee 2009; Ustun 2003; Valpas 2004). Five trials compared the variation in the surgical techniques and methods of laparoscopic colposuspension (444 women; Ankardal 2005; Persson 2000; Ross 1996; Wallwiener 1995; Zullo 2001).
Detailed information about the included trials can be found in the Characteristics of included studies.
Design
The included trials were RCTs or quasi‐RCTs of surgery for urinary incontinence, with laparoscopic colposuspension in at least one arm.
Sample sizes
Sample sizes ranged from 20 to 300, with 18 trials (68%) having fewer than 50 women in each arm.
Participants
The 26 included trials randomised a total of 2271 women. Judged on the trial reports, all participants had had prior urodynamic investigation, although this was only clearly stated in 22 trials (Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Maher 2004; Mirosh 2005; Paraiso 2004; Persson 2000; Persson 2002; Ross 1996; Su 1997; Samiee 2009; Stangel‐Wojcikiewicz 2008; Summitt 2000; Ustun 2003; Ustun 2005; Valpas 2004; Zullo 2001). Thus, all trials appeared to have been undertaken on women with urodynamic stress incontinence.
All but three of the included trials stated their exclusion criteria (Morris 2001; Tuygun 2006; Ustun 2003). Seventeen trials excluded women with previous continence surgery; eight did not (Carey 2006; Fatthy 2001; Foote 2006; Kitchener 2006; Maher 2004; Stangel‐Wojcikiewicz 2008; Tuygun 2006; Wallwiener 1995). For one of these trials, recurrent urinary stress incontinence was an inclusion criteria (Maher 2004). Twelve trials excluded women who had had previous retropubic surgery (Adile 2001; Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Foote 2006; Kitchener 2006; Mirosh 2005; Persson 2000; Samiee 2009; Summitt 2000; Zullo 2001).
Twelve trials excluded women with detrusor overactivity (Fatthy 2001; Foote 2006; Kitchener 2006; Mirosh 2005; Paraiso 2004; Ross 1996; Su 1997; Samiee 2009; Stangel‐Wojcikiewicz 2008; Summitt 2000; Ustun 2005; Valpas 2004), while one trial excluded women with urgency incontinence but included women with urgency symptoms (Persson 2000).
Twelve trials excluded women with varying degrees of pelvic organ prolapse (Fatthy 2001; Foote 2006; Maher 2004; Mirosh 2005; Paraiso 2004; Persson 2000; Persson 2002; Samiee 2009; Stangel‐Wojcikiewicz 2008; Su 1997; Wallwiener 1995; Zullo 2001).
Eight trials excluded women who required concomitant gynaecological operations, making the trial intervention a sole procedure (Adile 2001; Ankardal 2004; Ankardal 2005; Foote 2006; Mirosh 2005; Persson 2002; Summitt 2000; Valpas 2004).
Duration of follow‐up
All trials reported follow‐up outcomes within 18 months (short‐term), with the exception of one (Morris 2001). Five trials had a follow‐up time longer than 18 months and within five years (medium‐term; Adile 2001; Burton 1997; Kitchener 2006; Paraiso 2004; Tuygun 2006), while three trials reported on follow‐up after five years (long‐term; Burton 1997; Morris 2001; Paraiso 2004).
Interventions and comparators
Method of laparoscopic approach
Of the included 26 trials, 16 stated the method of approach used for the laparoscopic colposuspension. Ten trials used the transperitoneal approach (Ankardal 2004; Burton 1997; Carey 2006; Cheon 2003; Foote 2006; Persson 2000; Ross 1996; Summitt 2000; Ustun 2005; Zullo 2001), while five trials used the extraperitoneal approach (Fatthy 2001; Paraiso 2004; Samiee 2009; Tuygun 2006; Valpas 2004). One compared a transperitoneal with an extraperitoneal approach (Wallwiener 1995).
Laparoscopic compared with open colposuspension
Twelve trials compared laparoscopic colposuspension with open colposuspension but they were not consistent in either the number or type of mesh or sutures used (Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Morris 2001; Stangel‐Wojcikiewicz 2008; Summitt 2000; Tuygun 2006; Ustun 2005). Burton 1997 used absorbable Dexon sutures and Tuygun 2006 used polyglactin sutures, whereas seven trials used either non‐absorbable sutures (mainly Ethibond; Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Kitchener 2006; Su 1997; Summitt 2000), or polypropylene sutures (Fatthy 2001). With the exception of Ankardal 2004, all trials used the same number and type of suspension material for both the laparoscopic and open procedures. Ankardal 2004 used a polypropylene mesh and titanium staples for the laparoscopic colposuspensions and sutures for the open colposuspensions.
Laparoscopic colposuspension compared with midurethral sling procedures
Nine trials compared laparoscopic colposuspension with self‐fixing vaginal mesh slings (Adile 2001; Foote 2006; Maher 2004; Mirosh 2005; Paraiso 2004; Persson 2002; Samiee 2009; Ustun 2003; Valpas 2004). Seven of these studies used a TVT for the vaginal sling technique and one study used SPARC (Foote 2006), which is a midurethral sling similar to TVT but is inserted from above downwards rather than from below upwards. One study compared TOT with laparoscopic colposuspension using silk sutures (Samiee 2009), and one study used tacker mesh for the laparoscopic colposuspension (Valpas 2004), whereas four trials reported using two single‐bite non‐absorbable sutures each side (Foote 2006; Paraiso 2004; Persson 2002; Ustun 2003). The main differences between the interventions in this group was the type of anaesthesia used. In all trials, the laparoscopic colposuspensions were performed under a general anaesthetic. Further details about the anaesthesia were reported in six trials, with two reporting that the self‐fixing sling operations were performed under local anaesthetic with sedation (Persson 2002; Valpas 2004), under regional anaesthesia (spinal or epidural) in two trials (Adile 2001; Mirosh 2005), and a combination of general, regional and local with sedation in two other trials (Paraiso 2004; Ustun 2003).
One method of laparoscopic colposuspension versus another
Five trials compared different operative techniques or approaches for laparoscopic colposuspension (Ankardal 2005; Persson 2000; Ross 1996; Wallwiener 1995; Zullo 2001). Of these, three trials compared polypropylene mesh fixed with staples or tacks with Ethibond or Gore‐Tex sutures (Ankardal 2005; Ross 1996; Zullo 2001). Persson 2000 compared two single‐bite Gore‐Tex sutures with one double‐bite suture on each side of the urethra. Wallwiener 1995 compared extraperitoneal with transperitoneal access using Gore‐Tex sutures or mesh and staples.
Outcome measures
Fourteen trials reported subjective cure as a measure of operative success (Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Maher 2004; Morris 2001; Persson 2000; Persson 2002; Ustun 2003; Valpas 2004; Zullo 2001), although they used different instruments and scales to assess cure:
-
urine leakage reported by women;
-
use of pads; and
-
questionnaires completed by women.
Thirteen trials used objective measures in the form of a pad test or reported incontinence episodes (Ankardal 2004; Ankardal 2005; Burton 1997; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Morris 2001; Paraiso 2004; Persson 2000; Persson 2002; Su 1997; Valpas 2004). Eleven trials used urodynamic measurements pre‐ and postoperatively but put their emphasis on different parameters, not all using the measurements as their definition of cure (Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Maher 2004; Paraiso 2004; Ross 1996; Su 1997; Summitt 2000; Ustun 2003; Zullo 2001).
Ten trials assessed leakage observed by a health professional on a clinical stress test, which reported the data as objective cure rates. Six trials used negative urodynamic testing as their definition of cure (Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Stangel‐Wojcikiewicz 2008; Summitt 2000), while four trials used a negative pad test as their definition of objective cure (Ankardal 2004; Ankardal 2005; Kitchener 2006; Morris 2001).
Ten trials assessed quality of life as an outcome (Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Foote 2006; Kitchener 2006; Maher 2004; Mirosh 2005; Paraiso 2004; Valpas 2004). However, all the trials used various assessment questionnaires (e.g. Short Form 36 (SF‐36), King's Health Questionnaire (KHQ), Incontinence Impact Questionnaire (IIQ), Urogenital Distress Inventory (UDI)) and in differing combinations. Two trials that assessed quality of life did not report which validated questionnaire they used and did not report the results (Cheon 2003; Mirosh 2005).
All except three trials reported the number of perioperative complications and types of complications. One of these reported no major complications (Wallwiener 1995); the other two reported that the number of complications were similar in each arm (Maher 2004; Morris 2001).
Morris 2001 only reported on de novo detrusor overactivity after five years, which was similar in each arm. Maher 2004 reported de novo detrusor overactivity and voiding dysfunction. Both of these outcomes were found to be similar in each arm.
Excluded studies
We excluded nine trials from the review (ISRCTN44339585; Choi 2006; Foote 2007; Koster 1996; Lee 1997; Lernis 1997; NCT00573703; Prezioso 2013; Salam 2004). Four were either not RCTs or did not mention a randomisation process (Choi 2006; Lee 1997; Lernis 1997; Salam 2004). One prospective study had no comparator group (Prezioso 2013). One study was withdrawn as it did not start (NCT00573703). Another study did not assess laparoscopy for incontinence (Koster 1996). Personal correspondence with one trial author confirmed that one study did not start recruitment (ISRCTN44339585). In another study, randomisation broke down when one recruitment source only referred women for the laparoscopic procedure, leading to the trial continuing as a cohort study (Foote 2007).
More details can be found in the Characteristics of excluded studies.
Risk of bias in included studies
Figure 3 and Figure 4 summarise the 'Risk of bias' assessment for the included trials.
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study
Allocation
Random sequence generation
We judged 12 trials to be at low risk for sequence generation (Carey 2006; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Maher 2004; Paraiso 2004; Persson 2000; Persson 2002; Ustun 2005; Valpas 2004; Zullo 2001). We judged one trial to be high risk in this domain because of deviations from the randomisation and allocation procedure for participants who were not willing to undergo laparoscopic colposuspension (the trial authors did not report the number of participants for which this was the case; Su 1997). The remaining 13 trials did not report their methods in sufficient detail to judge whether allocation to groups was fully randomised and therefore were at unclear risk of bias (Adile 2001; Ankardal 2004; Ankardal 2005; Burton 1997; Mirosh 2005; Morris 2001; Ross 1996; Samiee 2009; Stangel‐Wojcikiewicz 2008; Summitt 2000; Tuygun 2006; Ustun 2003; Wallwiener 1995).
Allocation concealment
We judged 12 trials to be at low risk for allocation concealment (Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Paraiso 2004; Persson 2002; Persson 2000; Ross 1996; Ustun 2005; Valpas 2004). We judged one trial to be high risk in this domain because of deviations from the randomisation and allocation procedure for participants who were not willing to undergo laparoscopic colposuspension (the trial authors did not report the number of participants for which this was the case; Su 1997). The remaining 13 trials did not provide sufficient information to permit judgement and therefore we classified them as unclear (Adile 2001; Foote 2006; Kitchener 2006; Maher 2004; Mirosh 2005; Morris 2001; Samiee 2009; Stangel‐Wojcikiewicz 2008; Summitt 2000; Tuygun 2006; Ustun 2003; Wallwiener 1995; Zullo 2001).
Blinding
Blinding of participants and care givers (performance bias
We judged only one trial to be at low risk of performance bias in terms of blinding (Carey 2006). In this trial, participants and assessors were blinded in that the abdominal wounds were dressed in theatre in an identical fashion. As such, both participants and ward staff were masked to the procedure performed until the removal of dressings prior to discharge. For the remainder of the trials, we judged the risk of performance bias to be unclear on the grounds that blinding of participants and care givers is generally not possible in the context of surgical trials; it is not clear the extent to which knowledge of the intervention allocated could have an impact on outcomes.
Furthermore, it was unclear the degree to which performance bias may have been present due to the surgical learning curve. The surgeons in three trials had performed fewer than 20 laparoscopic colposuspensions before starting the trial (Burton 1997; Cheon 2003; Fatthy 2001). Other trials either reported surgeons as being senior gynaecologists with extensive experience in both procedures (Ankardal 2004; Ankardal 2005; Carey 2006; Kitchener 2006), or did not report the experience of the surgeons (Morris 2001; Summitt 2000).
Blinding of outcome assessors (detection bias)
We judged one trial to be at high risk of detection bias because the same physician who operated on the participants also performed the follow‐up evaluations and interviews without being blinded (Persson 2000). Three trials employed adequate methods of blinding of outcome assessors and we therefore judged them to be at low risk of detection bias (Paraiso 2004; Persson 2002; Zullo 2001). We judged the remaining trials to be unclear in terms of risk of detection bias because they did not report sufficient detail with regard to blinding of outcome assessors.
Incomplete outcome data
Nineteen trials reported sufficient information regarding attrition to be judged at low risk of attrition bias; generally they reported no differential attrition, provided adequate explanations for losses to follow‐up and/or carried out intention‐to‐treat analysis (Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Maher 2004; Mirosh 2005; Morris 2001; Paraiso 2004; Persson 2002; Ross 1996; Stangel‐Wojcikiewicz 2008; Su 1997; Ustun 2003; Ustun 2005; Valpas 2004; Zullo 2001).
We judged the following seven trials to be unclear due to insufficient information (Adile 2001; Burton 1997; Persson 2000; Samiee 2009; Summitt 2000; Tuygun 2006; Wallwiener 1995).
Selective reporting
We judged 18 trials to be at low risk of reporting bias (Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Maher 2004; Paraiso 2004; Persson 2000; Persson 2002; Ross 1996; Su 1997; Tuygun 2006; Ustun 2005; Valpas 2004; Zullo 2001). We judged one trial to be at high risk (Ustun 2003), while we judged seven trials to be unclear (Adile 2001; Mirosh 2005; Morris 2001; Samiee 2009; Stangel‐Wojcikiewicz 2008; Summitt 2000; Wallwiener 1995).
Other potential sources of bias
Persson 2000 set out to enrol 280 participants but the trial authors became convinced during follow‐up that one trial arm had a higher cure rate. For ethical reasons, they therefore performed an interim analysis on the objective one‐year cure rate on 108 participants, which confirmed a higher cure rate in one group. Thereafter, further enrolment was stopped and only the 161 participants who had already been recruited were followed up; the analysis was adjusted for the early stopping. We judged this trial to be at unclear risk of bias, as the early stoppage may have had an impact on the overall result.
In one trial, the number of women recruited fell short of the target, owing to limitations of time and recruiting problems (Valpas 2004). As a result, this study was also stopped prematurely. However, the trial authors still considered the groups to be comparable and they analysed data without adjustment after stopping the study. We judged this trial to be at unclear risk of bias, as it was not clear if this could have had an impact on the overall result.
We judged seven other trials that were published as conference abstracts to be unclear regarding other potential sources of bias (Adile 2001; Burton 1997; Maher 2004; Mirosh 2005; Morris 2001; Stangel‐Wojcikiewicz 2008; Summitt 2000). We judged the remaining 17 trials to be at low risk of bias (Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Fatthy 2001; Foote 2006; Kitchener 2006; Paraiso 2004; Persson 2002; Ross 1996; Samiee 2009; Su 1997; Tuygun 2006; Ustun 2003; Ustun 2005; Wallwiener 1995; Zullo 2001).
Effects of interventions
See: Summary of findings for the main comparison Laparoscopic colposuspension compared to open colposuspension for urinary incontinence in women; Summary of findings 2 Laparoscopic colposuspension compared to midurethral sling procedures for urinary incontinence in women; Summary of findings 3 Laparoscopic colposuspension with one suture compared to laparoscopic colposuspension with two sutures for urinary incontinence in women; Summary of findings 4 Laparoscopic colposuspension with sutures compared to laparoscopic colposuspension with mesh and staples for urinary incontinence in women
1. Laparoscopic colposuspension versus no treatment or sham operation
We did not find any eligible trials.
2. Laparoscopic colposuspension versus conservative interventions (e.g. pelvic floor muscle training, electrical stimulation, cones, biofeedback)
We did not find any eligible trials.
3. Laparoscopic colposuspension versus open colposuspension
Thirteen trials compared laparoscopic with open colposuspension (Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Morris 2001; Summitt 2000; Stangel‐Wojcikiewicz 2008; Su 1997; Tuygun 2006; Ustun 2005). We later subgrouped these into those trials that utilised sutures to carry out the colposuspension and those trials that used mesh and staples. This addressed the statistically significant heterogeneity reflected in some of the results when combining different methods of carrying out the colposuspension.
All the trials had different lengths of follow‐up: one trial for six months (Carey 2006); five trials for one year (Ankardal 2004; Ankardal 2005; Cheon 2003; Su 1997; Summitt 2000); one trial for 6 and 18 months (Fatthy 2001); one trial for 6, 12 and 24 months (Kitchener 2006); one trial for six months, one year, three years and five years (Burton 1997); one trial from 18 months to five years (Tuygun 2006); and two trials for 18 months (Stangel‐Wojcikiewicz 2008; Ustun 2005).
Outcome data for six to 18 months' follow‐up were therefore available for 10 trials. Longer‐term data, over five years, were only available for two trials (Burton 1997; Morris 2001). Morris 2001 had only five‐ to seven‐year follow‐up data, with no earlier follow‐up results reported. The ability to synthesise data was also limited by the variable tests and definitions used to measure subjective and objective outcomes across the trials and failure to report standard deviations.
Primary outcomes
Subjective cure of urinary incontinence within 18 months
The pooled RR for subjective cure of urinary incontinence within 18 months after laparoscopic colposuspension relative to open colposuspension was 0.92 (95% CI 0.81 to 1.05; 1117 women; Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Tuygun 2006; Ustun 2005; Analysis 1.1). The test for subgroup differences indicated heterogeneity between subgroups (P < 0.00001). The 95% CIs of the two summary estimates do not overlap, which suggests that using sutures or mesh and staples has different effects. Within 18 months, there is little difference between laparoscopic colposuspension using sutures and open colposuspension in terms of subjective cure (RR 1.04, 95% CI 0.99 to 1.08, 755 women; Ankardal 2005; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Ustun 2005; high‐quality evidence; Analysis 1.1;summary of findings Table for the main comparison). We are uncertain whether there is any difference in subjective cure between laparoscopic colposuspension (using mesh and staples) and open colposuspension (RR 0.75, 95% CI 0.61 to 0.93, 362 women; Ankardal 2004; Ankardal 2005; Tuygun 2006; very low‐quality evidence; Analysis 1.1;summary of findings Table for the main comparison).
Subjective cure of urinary incontinence after 18 months and within five years
Two trials reported subjective cure at between 18 months and five years' follow‐up (Kitchener 2006; Tuygun 2006). There appears to be little difference between laparoscopic colposuspension and open colposuspension (RR 0.94, 95% CI 0.77 to 1.14; 323 women; Analysis 1.2).
The test for subgroup differences regarding laparoscopic colposuspension with sutures and laparoscopic colposuspension with mesh and staples did not identify evidence of heterogeneity (P = 0.16) and the 95% CIs of the two summary estimates overlapped closely. Therefore, there was no evidence that the effects may be different in these two subgroups.
Subjective cure of urinary incontinence after five years
At five years' follow‐up, one trial found no evidence of a difference in subjective cure rates between women undergoing laparoscopic colposuspension and those undergoing open colposuspension (RR 1.53, 95% CI 1.00 to 2.35; 64 women; Morris 2001). One trial measured subjective cure on a 1 to 10 visual analogue scale (VAS), where a higher score equals a better outcome (Burton 1997). At five‐year follow‐up, the mean score in the laparoscopic group was 9.4, compared to 4.4 in the open group.
Secondary outcomes
Women's observations
None of the included studies reported this outcome.
Quantification of symptoms
Two trials used different methods to quantify symptoms. There appeared to be little difference between the groups in incontinence episodes per 24 hours at 18 months' follow‐up in one trial (MD −0.12 episodes, 95% CI −0.68 to 0.92; 73 women; Fatthy 2001). Another trial reported more incontinence episodes per 24 hours in the laparoscopic group than in the open group at 18 months' follow‐up but reported data without standard deviations (6 versus 2, 30 women in each group; Burton 1997).
Objective cure (clinicians' measures)
There appears to be little or no difference between laparoscopic and open colposuspension in terms of objective cure within 18 months (RR 0.94, 95% CI 0.86 to 1.02; 1117 women; Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Summitt 2000; Ustun 2005; Analysis 1.3).
It is not clear if the effect may be different depending on whether laparoscopic colposuspension is performed with sutures or with mesh and staples, according to the test for subgroup differences (P = 0.01 and overlapping 95% CIs).
The analysis for objective cure rates between 18 months and five years showed no evidence of a difference between laparoscopic and open colposuspension, using random‐effects analysis due to the different directions of effect in the two trials (RR 0.82, 95% CI 0.41 to 1.63; 290 women; Burton 1997; Kitchener 2006; Analysis 1.4).
At five‐year follow‐up, there was no evidence of a difference in objective cure rates between laparoscopic and open colposuspension using random‐effects analysis due to the different directions of effect in the two trials (RR 0.89, 95% CI 0.28 to 2.80; 107 women; Burton 1997; Morris 2001; Analysis 1.5).
Quality of life
Five trials measured quality of life using a variety of questionnaires (Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Kitchener 2006; Table 1). The evidence is summarised below.
| Laparoscopic colposuspension versus open colposuspension | |||
| Study | Outcome | Laparoscopic | Open |
| VAS scores (median, range): Physical activity Working ability Social life Sexual life | 1 (0‐47) 0 (0‐13) 0 (0‐20) 0 (0‐10) | 0 (0‐4) 0 (0‐0) 0 (0‐0) 0 (0‐0) | |
| VAS scores (median, range): Physical activity Working ability Social life Sexual life | (mesh) 2 (0‐44) 0 (0‐16) 0 (0‐20) 0 (0‐18) | 0 (0‐2) 0 (0‐0) 0 (0‐0) 0 (0‐0) | |
| VAS scores (median, range): Physical activity Working ability Social life Sexual life | (sutures) 0 (0‐0) 0 (0‐0) 0 (0‐0) 0 (0‐0) | 0 (0‐2) 0 (0‐0) 0 (0‐0) 0 (0‐0) | |
| SF‐36 General Health (mean, SD)a | 2.60 (1.02) | 2.22 (1.06) | |
| SUDI (mean, SD)b | 23.92 (17.90) | 21.56 (16.92) | |
| SIIQb | 31.40 (23.83) | 26.87 (29.36) | |
| VAS scores (mean, SD): Return to normal activity (days) | 22.2 (15.9) | 29.3 (19.8) | |
| SF‐36 (mean, SD): physical subscalea SF‐36 (mean, SD): mental subscalea | 79.32 (27.59) 69.51 (21.21) | 77.60 (27.74) 69.38 (22.65) | |
| EQ‐5D (mean, SD)b | 0.844 (0.259) | 0.825 (0.270) | |
| Mean (SD) total costs | GBP 1805 (471) | GBP 1433 (362) | |
| QALYs at 2 years (mean) | 1.677 | 1.637 | |
| EQ‐5D: EuroQuol generic health questionnaire; QALY: quality‐adjusted life years; SD: standard deviation; SF‐36: short‐form 36 item health survey; SIIQ: Short Incontinence Impact Questionnaire; SUDI: Short Urinary Distress Inventory; VAS: visual analogue scale | |||
aHigher score = greater quality of life.
bLower score = greater quality of life.
One trial used the SF‐36, SUDI (Short Urogenital Distress Inventory) and IIQ questionnaires (Carey 2006). Both the SUDI and IIQ scores equally improved postoperatively in the two groups but no further details were available.
Two trials used a VAS to assess symptoms of 'bother' caused and their impact on different quality of life domains (Ankardal 2004; Ankardal 2005). In one trial the improvement was greater in the open colposuspension group with regard to physical activity one year after surgery (Ankardal 2004).
One trial used a number of validated questionnaires (Kitchener 2006). These included SF‐36, the Bristol Female Lower Urinary Tract Symptom Questionnaire (BFLUTS), Symptom Severity and Symptom Impact Index and the EQ‐5D‐3L. Kitchener 2006 reported results for the SF‐36 and EQ‐5D‐3L and showed that both treatment arms had improved scores after two years with no evidence of a difference between groups.
One trial assessed quality of life but details of the instrument used and further results were lacking in the trial report (Cheon 2003).
Surgical outcome measures
Repeat continence surgery
In one trial, at five years' follow‐up three out of 30 women (10%) in the laparoscopic group in one trial had repeat continence surgery compared with none out of 30 in the open group (Burton 1997). None of the other trials reported this outcome.
Pain or analgesia requirements
Women who underwent a laparoscopic colposuspension appeared to have significantly less pain and needed less postoperative analgesia but the trials did not present data in a form suitable for quantitative synthesis (Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Tuygun 2006).
Length of inpatient stay
All trials, with the exception of Morris 2001, reported the length of hospital stay to be longer for open colposuspension. Eight trials reported data in such a way that could be analysed, favouring laparoscopic colposuspension due to a shorter hospital stay (MD −1.20 days, 95% CI −1.84 to −0.56; 1142 women; Ankardal 2004; Ankardal 2005; Carey 2006; Cheon 2003; Kitchener 2006; Stangel‐Wojcikiewicz 2008; Summitt 2000; Tuygun 2006; Analysis 1.6).
Time to return to normal activity level
Where reported, the time to return to normal activities was significantly longer for open colposuspension (MD −14.27 days, 95% CI −25.17 to −3.38; 401 women; Carey 2006; Cheon 2003; Fatthy 2001; Tuygun 2006; Analysis 1.7).
Operation time
Laparoscopic colposuspension with either sutures or with mesh and staples took significantly longer than open colposuspension (sutures: MD 25.27 minutes, 95% CI 6.21 to 44.33; 549 women; mesh and staples MD 16.77 minutes; 95% CI 6.59 to 26.95; 379 women; Ankardal 2004; Ankardal 2005; Carey 2006; Fatthy 2001; Su 1997; Summitt 2000; Tuygun 2006; Analysis 1.8). We analysed the data with a random‐effects model because there was significant heterogeneity (I² = 94%), probably due to a combination of factors such as the considerable variation in operation times reported in the trials, the different definitions of operation time used by the trial authors and the different levels of experience of the surgeons performing the operations.
Blood loss
Based on nine trials, the estimated blood loss was higher in the open groups (MD −87.64 mL, 95% CI −141.70 to −33.58; 940 women; Ankardal 2004; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Stangel‐Wojcikiewicz 2008; Su 1997; Summitt 2000; Tuygun 2006; Analysis 1.9).
Duration of catheterisation
While six trials reported the mean duration of catheterisation, only four reported their data with standard deviations (Ankardal 2004; Cheon 2003; Su 1997; Tuygun 2006). It appeared that women undergoing laparoscopic colposuspension required less catheterisation time than those having open colposuspension, (MD −2.39 days, 95% CI −3.48 to −1.30; 449 women; Analysis 1.10).
Adverse effects
Perioperative complications
Laparoscopic colposuspension may slightly reduce the risk of perioperative complications compared with open colposuspension (RR 0.67, 95% CI 0.47 to 0.94; 1369 women; Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Su 1997; Summitt 2000; Tuygun 2006; Ustun 2005; low‐quality evidence; Analysis 1.11; summary of findings Table for the main comparison). The test for subgroup differences indicated little evidence of heterogeneity between subgroups, which could be due to different kinds of laparoscopic colposuspension (P = 0.60). Furthermore, the 95% CIs of the two summary estimates overlapped closely, so it may be that laparoscopic colposuspension using sutures compared with open colposuspension does not have a different effect from laparoscopic colposuspension using mesh and staples.
In terms of bladder perforation, there may be similar or higher rates with laparoscopic colposuspension compared with open colposuspension (RR 1.72, 95% CI 0.90 to 3.29; 1311 women; Ankardal 2004; Ankardal 2005; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Kitchener 2006; Stangel‐Wojcikiewicz 2008; Tuygun 2006; Ustun 2005; moderate‐quality evidence; Analysis 1.12; summary of findings Table for the main comparison).
With respect to the test for subgroup differences regarding laparoscopic colposuspension with sutures and laparoscopic colposuspension with mesh and staples, there was no evidence of heterogeneity (P = 0.29) and the 95% CIs of the two summary estimates overlapped closely. Therefore, there is little indication that the effects may be different in these two subgroups. Two trials reported cases of laceration to the obturator vein during laparoscopic colposuspension (Carey 2006; Summitt 2000).
De novo detrusor overactivity
Whether laparoscopic colposuspension or open colposuspension is used probably makes little difference in terms of de novo detrusor overactivity within 18 months (RR 1.29, 95% CI 0.72 to 2.30; 472 women; Burton 1997; Carey 2006; Cheon 2003; Fatthy 2001; Ustun 2005; moderate‐quality evidence; Analysis 1.13). However, the confidence intervals are wide and cross the line of no effect, spanning both benefits and harms, so differences between the two procedures are not apparent.
It is uncertain whether laparoscopic colposuspension increases the risk of de novo detrusor overactivity in the long‐term (RR for 18 months to 5 years 1.00, 95% CI 0.07 to 15.12 and RR for more than 5 years 1.22, 95% CI 0.40 to 3.75; Burton 1997; Morris 2001; Analysis 1.13).
Voiding dysfunction
There is probably little difference between laparoscopic and open colposuspension in terms of voiding dysfunction (RR 0.81, 95% CI 0.50 to 1.31; 507 women; Burton 1997; Carey 2006; Cheon 2003; Stangel‐Wojcikiewicz 2008; Ustun 2005; moderate‐quality evidence; Analysis 1.14; summary of findings Table for the main comparison). However, the confidence intervals are wide and cross the line of no effect, spanning both benefits and harms, so differences between the two procedures are not apparent.
4. Laparoscopic colposuspension versus traditional sling procedures
We did not find any eligible trials.
5. Laparoscopic colposuspension versus midurethral sling procedures
Nine trials investigated laparoscopic colposuspension with newer 'self‐fixing' sling procedures (Adile 2001; Foote 2006; Maher 2004; Mirosh 2005; Paraiso 2004; Persson 2002; Samiee 2009; Ustun 2003; Valpas 2004). Within these nine trials there were variations in the techniques (TVT, TOT or SPARC slings) and type of material (sutures or mesh) used for both of the procedures. For this reason, we used subgroups within the comparison graphs. All trials reported data within 18 months and five of the them had follow‐up at one year postoperatively (Foote 2006; Paraiso 2004; Persson 2002; Mirosh 2005; Valpas 2004). The ability to synthesise data was limited in some areas by the variation in tests and definitions used for subjective and objective outcomes. For this reason, we have reported some data in Table 2. A published supplementary version of one trial reported long‐term follow‐up (four to eight years) (Paraiso 2004).
| Study | Outcome | Laparoscopic colposuspension | Midurethral slings |
| Quality of life | |||
| YQ and UDI | No evidence of a difference between groups | ||
| SUDI, SIIQ, SF‐36 | No evidence of a difference between groups | ||
| SF‐36 to assess quality of life. Symptom distress for urinary incontinence in women with the IIQ and the UDI | No evidence of a difference between groups | ||
| UDI‐6 and IIQ‐7 | No evidence of a difference between groups | ||
| SUDI, SIIQ, SF‐36 | No significant difference between the two groups | ||
| SF‐36 to assess quality of life. Symptom distress for urinary incontinence in women with the IIQ and the UDI | No evidence of a difference between groups | ||
| UDI‐6 and IIQ‐7 | No evidence of a difference between groups | ||
| I‐QOL, UDI‐6 and ISI | I‐QOL: "significantly increased in both groups after 6 months of operation (p<0.05). But the differences were not statistically significant". UDI‐6: improvement in urgency was significant in TOT compared to Burch (P = 0.04) ISI: subjective cure rate following surgery showing no evidence of a difference between groups (P = 0.23) | ||
| Womens' observations | |||
| PGII at 1 year Procedure met woman’s expectation
Would recommend to a friend
PGII at 3 years Procedure met woman’s expectation
Would recommend to a friend
PGII at 5 years Procedure met woman’s expectation
Would recommend to a friend
| 58.8% 27.5% 7.8% 74.5% 15.7% 3.9% 64.7% 21.6% 5.9% 76.5% 9.8% 3.9% 51.0% 23.5% 3.9% 66.7% 7.8% 5.9% | 82.9% 11.4% 0% 92.9% 1.4% 0% 71.4% 7.1% 0% 77.1% 2.9% 0% 64.3% 8.6% 0% 67.1% 23.5% 3.9% | |
| UISSa (0–20; mean, SD at 5 years) | 3.4 (4.0) | 1.8 (3.4) | |
| Surgical costs | |||
| AUD 3388 | AUD 3633 | ||
| lap USD 6368 | USD 6059 | ||
| EUR 1273.40 | EUR 1342.80 | ||
| EUR 1342.80 | EUR 1180.10 | ||
| Mean duration of catheterisation | |||
| 2.7 days (2.6) | 1.4 days (2.1) | ||
| lap 4.9 days | 5.2 days | ||
| 3 days (range 1‐5) | 1 days (range 0‐7) | ||
| 24.4 h | 9.2 h | ||
| IIQ: Incontinence Impact Questionnaire;ISI: Incontinence Symptom Index; I‐QOL: Incontinence Quality of Life; PGII: Patients' Global Impression of Improvement; SD: standard deviation; SF‐36: short‐form 36 item health survey; SIIQ: Short Incontinence Impact Questionnaire; SUDI: Short Urinary Distress Inventory; UDI: Urogenital Distress Inventory; UISS: Urinary Incontinence Severity Score; YQ: York Quality of life | |||
aLower score = greater quality of life.
Primary outcomes
Subjective cure of urinary incontinence within 18 months
The pooled RR for subjective cure of urinary incontinence within 18 months after laparoscopic colposuspension relative to midurethral slings was 0.91 (95% CI 0.80 to 1.02; 377 women; Foote 2006; Maher 2004; Persson 2002; Ustun 2003; Valpas 2004; Analysis 2.1). There may be little difference between laparoscopic colposuspension with sutures in terms of subjective cure compared to midurethral slings (RR 1.01, 95% CI 0.88 to 1.16; 256 women; Foote 2006; Maher 2004; Persson 2002; Ustun 2003; low‐quality evidence; Analysis 2.1; summary of findings Table 2). Open colposuspension may be more effective than laparoscopic colposuspension with mesh in terms of subjective cure (RR 0.71, 95% CI 0.55 to 0.91; 121 women; Valpas 2004; Analysis 2.1; summary of findings Table 2; low‐quality evidence). There was little evidence of heterogeneity (P = 0.02) and the 95% CIs of the two summary estimates overlapped closely. Therefore there is little indication that the effects may be different in these two subgroups.
Subjective cure of urinary incontinence after 18 months and within five years
At 18 months to five years' follow‐up, based on one small trial, there was no evidence of a difference in subjective cure between laparoscopic colposuspension and midurethral slings (RR 1.18, 95% CI 0.36, 3.81; 53 women; Paraiso 2004).
Subjective cure of urinary incontinence after five years
None of the trials reported this outcome.
Secondary outcomes
Women's observations
Data from two small trials showed no evidence of a difference in urgency symptoms (de novo symptoms) between laparoscopic colposuspension and midurethral slings (RR 0.44, 95% CI 0.13 to 1.47; 201 women; Foote 2006; Valpas 2004; Analysis 2.2).
Quantification of symptoms
Data from two trials suggested that women who had laparoscopic colposuspension had fewer incontinence episodes per week than those who had midurethral slings (MD −1.40 episodes, 95% CI −2.07 to −0.73; 150 women; Foote 2006; Paraiso 2004; Analysis 2.3).
One trial reported pad test data but not in a way suitable for analysis (Valpas 2004).
Objective cure (clinicians' measures)
Midurethral slings appear to be slightly better than laparoscopic colposuspension in terms of objective cure within 18 months (RR 0.88 95% CI 0.81 to 0.95; 575 women; Adile 2001; Foote 2006; Maher 2004; Paraiso 2004; Persson 2002; Ustun 2003; Valpas 2004; Analysis 2.4). It is not clear if the effect may be different depending on whether laparoscopic colposuspension is performed with sutures or with mesh, according to the test for subgroup differences (P = 0.01 and overlapping 95% confidence intervals). Furthermore, we cannot draw firm conclusions because there was only one trial in the mesh and staples subgroup.
Samiee 2009 reported objective cure rates of 75% for laparoscopic colposuspension and 84.20% TOT, which was determined by no urinary leakage during stress and analysed with urodynamic evaluation, However, they did not specify the method of laparoscopic colposuspension in the non‐translated full‐text of the paper.
Quality of life
Six trials measured quality of life using various validated instruments (UDI, IIQ, SF‐36, KHQ and VAS; Foote 2006; Maher 2004; Mirosh 2005; Paraiso 2004; Samiee 2009; Valpas 2004). The trials collected quality‐of‐life evidence using a range of validated questionnaires and the data indicated little evidence of a difference between the groups (Table 2).
Surgical outcome measures
Repeat continence surgery
There may be lower rates of repeat continence surgery for laparoscopic colposuspension compared with midurethral slings, however, the confidence intervals are very wide and cross the line of no effect, spanning both benefits and harms, so differences between the two procedures are not apparent (low‐quality evidence; summary of findings Table 2). One trial reported that one out of 32 women and three out of 38 women underwent repeat continence surgery in the laparoscopic colposuspension and midurethral slings groups respectively (RR 0.40, 95% CI 0.04 to 3.62; 70 women; Persson 2002).
Pain or analgesia requirements
Only two trials assessed the use of postoperative analgesia and pain relief (Paraiso 2004; Valpas 2004). Valpas 2004 reported that the use and doses of analgesics were lower in the TVT group, whereas Paraiso 2004 found little difference between the length of time (in hours) that patient‐controlled analgesia (PCA) was used in the groups. The data were unsuitable for meta‐analysis.
Length of inpatient stay
Based on data from two trials, the length of inpatient stay was longer for women undergoing laparoscopic colposuspension than for those undergoing midurethral sling procedures (MD 1.06 days, 95% CI 0.59 to 1.53, 128 women; Maher 2004; Ustun 2003). When we included data from trials where we imputed standard deviations, the mean difference was greater and with narrower 95% CIs (MD 1.18 days, 95% CI 0.82 to 1.55, 322 women; Foote 2006; Maher 2004; Mirosh 2005; Ustun 2003; Valpas 2004; Analysis 2.5).
Time to return to normal activity level
Where reported, the time to return to normal activities was longer for laparoscopic colposuspension (MD 7.14 days, 95% CI 4.60 to 9.67; 280 women; Foote 2006; Maher 2004; Valpas 2004; Analysis 2.6).
Operation time
Laparoscopic surgery took longer than midurethral sling surgery (MD 26.26 minutes, 95% CI 6.57 to 45.95; 198 women; Maher 2004; Persson 2002; Ustun 2003). However, it is unclear if this is a clinically important difference.
In analysing operation time, when we included the trials where we imputed standard deviations, the mean difference was greater and with narrower 95% CIs (MD 25.85 minutes, 95% CI 13.56 to 38.13; 392 women; Foote 2006; Maher 2004; Mirosh 2005; Persson 2002; Ustun 2003; Valpas 2004; Analysis 2.7). We used a random‐effects model to analyse the data because there was significant heterogeneity (I² = 87%), probably due to a combination of factors such as the considerable variation in the operation times reported in the trials, the different definitions of operation time used by the trial authors and the different levels of experience of the surgeons performing the operations.
Blood loss
None of the trials reported this outcome.
Duration of catheterisation
Four trials reported the duration of indwelling catheterisation but the data were not suitable for meta‐analysis (see Table 2).
Adverse effects
Perioperative complications
Seven of the trials reported perioperative complications (Adile 2001; Foote 2006; Mirosh 2005; Paraiso 2004; Persson 2000; Ustun 2003; Valpas 2004). There may be no evidence of a difference between laparoscopic colposuspension and midurethral slings in terms of perioperative complication rates (RR 0.99, 95% CI 0.60 to 1.64; 514 women; low‐quality evidence; Analysis 2.8; summary of findings Table 2). With respect to the test for subgroup differences regarding laparoscopic colposuspension with sutures and laparoscopic colposuspension with mesh and staples, there was no evidence of heterogeneity (P = 0.17) and the 95% CIs of the two summary estimates overlapped. This suggests that there may be little difference in effects between these two subgroups but we cannot draw firm conclusions because there was only one trial in the mesh and staples group.
None of the trials reported bladder perforations.
De novo detrusor overactivity
There may be no evidence of a difference between laparoscopic colposuspension and midurethral slings in de novo detrusor overactivity within 18 months because we assessed the quality of evidence as low (RR 0.80, 95% CI 0.34 to 1.88; 326 women; Adile 2001; Maher 2004; Paraiso 2004; Ustun 2003; low‐quality evidence; Analysis 2.9; summary of findings Table 2).
Voiding dysfunction
There is probably little difference between laparoscopic colposuspension and midurethral slings in terms of voiding dysfunction (RR 1.06, 95% CI 0.47 to 2.41; 412; Foote 2006; Maher 2004; Paraiso 2004; Persson 2002; Valpas 2004; moderate‐quality evidence; Analysis 2.10; summary of findings Table 2). However, the confidence intervals are wide and cross the line of no effect, spanning both benefits and harms, so differences between the two procedures are not apparent.
With respect to the test for subgroup differences regarding laparoscopic colposuspension with sutures and laparoscopic colposuspension with mesh and staples, there was no evidence of heterogeneity (P = 0.77) and the 95% CIs of the two summary estimates overlapped closely. This suggests that there may be little difference in effects between these two subgroups but we cannot draw firm conclusions because there was only one trial in the mesh and staples group.
6. Laparoscopic colposuspension versus needle suspension
We did not find any eligible trials.
7. Laparoscopic colposuspension versus anterior vaginal repair
We did not find any eligible trials.
8. Laparoscopic colposuspension versus periurethral injections
We did not find any eligible trials.
9. One method of laparoscopic colposuspension versus another
Five trials (444 participants) looked at different methods of laparoscopic colposuspension (Ankardal 2005; Persson 2000; Ross 1996; Wallwiener 1995; Zullo 2001). One compared one double‐bite suture with two single‐bite sutures each side of the urethra (Persson 2000). Three compared mesh and staples with sutures (Ankardal 2005; Ross 1996; Zullo 2001). One trial compared two different methods of laparoscopic approach (Wallwiener 1995).
Wallwiener 1995 compared a transperitoneal approach with an extraperitoneal approach for laparoscopic colposuspension, and used a mixture of sutures or mesh stapler fixation; it was not clear which method of fixation they used with which operation. The sample size was small (22 women). Overall, 18 out of 22 women were subjectively and objectively cured; no data were reported per treatment group.
Primary outcomes
Subjective cure of urinary incontinence within 18 months
Laparoscopic colposuspension with two sutures versus laparoscopic colposuspension with one suture
Low‐quality evidence from one trial indicated that there may be significantly more women reporting subjective cure after undergoing laparoscopic colposuspension with two sutures (72/81 women) than those undergoing the procedure with one suture (50/77 women), within 18 months of surgery (RR 1.37, 95% CI 1.14 to 1.64; 158 women; Persson 2000; summary of findings Table 3).
Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples
One trial comparing sutures to mesh and staples did not report subjective measures of cure or improvement (Ross 1996). It is uncertain whether laparoscopic colposuspension with sutures leads to better subjective cure rates compared with laparoscopic colposuspension with mesh within 18 months (RR 1.28, 95% CI 1.11 to 1.47; 180 women; Ankardal 2005; Zullo 2001; very low‐quality evidence; Analysis 3.1; summary of findings Table 4). There was evidence of heterogeneity (I² = 73%), which is unlikely to be attributable to differences between the trials since both had similar participant characteristics and both used VASs to assess subjective perception of incontinence. To address this heterogeneity, we performed a random‐effects meta‐analysis (RR 1.24, 95% CI 0.96 to 1.59), which suggests there may be little difference in terms of subjective cure when comparing sutures with mesh and staples.
Subjective cure of urinary incontinence after 18 months and within five years
Laparoscopic colposuspension with two sutures versus laparoscopic colposuspension with one suture
Not reported.
Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples
The only trial comparing mesh and staples with sutures that also contained data beyond 18 months' follow‐up reported that the subjective cure rate was significantly (P < 0.05) higher in the sutures group than in the mesh and staples group at both 24 and 36 months (Zullo 2001). This trial reported the subjective outcomes as subjective failure rates as opposed to subjective cure rates and evaluated them using a VAS. They reported that subjective failure rate was significantly (P < 0.05) lower in the sutures group than in the mesh and staples group 24 months (20.0% versus 36.7%, respectively), and 36 months (33.3% versus 53.3%, respectively) after surgery. The same study went on to conclude that laparoscopic colposuspension performed with sutures is more effective than laparoscopic colposuspension accomplished with the use of prolene meshes in the long term, and the use of prolene meshes should be avoided in the treatment of stress incontinence.
Subjective cure of urinary incontinence after five years
None of the studies reported this outcome.
Secondary outcomes
Women's observations
In one trial comparing one double‐bite suture with two single‐bite sutures, a higher proportion of women in the one‐suture group reported postoperative urgency symptoms than in the two‐suture group (6/78, 7.8% compared to 4/83, 4.9%; Persson 2000).
Quantification of symptoms
None of the studies reported this outcome.
Objective cure (clinicians' measures)
In one trial comparing one double‐bite suture with two single‐bite sutures, the objective cure rate was significantly higher in the two‐suture group than in the one‐suture group (RR 1.42, 95% CI 1.14 to 1.77; 149 women; Persson 2000).
All trials comparing mesh and staples with sutures defined objective failure as leakage observed on the clinical stress test. The random‐effects meta‐analysis, carried out because of the different directions of effect observed in the trials, indicated that there may be no difference within 18 months' follow‐up between laparoscopic colposuspension with mesh and with sutures (RR 1.17, 95% CI 0.89 to 1.55; 243 women; Ankardal 2005; Ross 1996; Zullo 2001).
One small trial comparing mesh and staples with sutures presented data at three‐year follow‐up, which also indicated no evidence of a difference between the groups (RR 1.50, 95% CI 0.83 to 2.70; 52 women; Zullo 2001).
Quality of life
None of the studies reported this outcome.
Surgical outcome measures
Repeat continence surgery
Based on low‐quality evidence from a single trial, there may be little difference between laparoscopic colposuspension with one or two sutures in terms of repeat continence surgery. One woman in the two‐suture group (80 women) had repeat continence surgery, compared to none in the one‐suture group (RR 0.35, 95% CI 0.01 to 8.37; 157 women; Persson 2000; summary of findings Table 3).
We cannot be certain if there is any difference in the numbers of women undergoing repeat continence surgery between laparoscopic colposuspension with sutures (1/35 women) and laparoscopic colposuspension with mesh and sutures (1/34 women) because we assessed the quality of evidence as very low (RR 0.97, 95% CI 0.06 to 14.91; Ross 1996; summary of findings Table 4).
Pain or analgesia requirements
None of the studies reported this outcome.
Length of inpatient stay
In one trial comparing one double‐bite suture with two single‐bite sutures, the median length of hospital stay was 1.7 days in both groups (Persson 2000).
In two trials comparing mesh and staples with sutures, length of hospital stay was the same regardless of whether sutures or mesh were used (Ross 1996; Zullo 2001). In one trial, the length of hospital stay was shorter in the mesh group (mean 2.1, SD 1.3 days) than in the sutures group (mean 3.3, SD 2.5 days; Ankardal 2005).
Time to return to normal activity level
None of the studies reported this outcome.
Operation time
In one trial comparing one double‐bite suture with two single‐bite sutures, the median operating time was 17 minutes longer among those allocated to two sutures (Persson 2000).
Ankardal 2005 reported longer operating time for sutures (mean 84, SD 30 minutes) compared to mesh and staples (74, SD 25 minutes). The same trial also reported longer catheterisation time for sutures (mean 6.2, SD 9.2 days) than for mesh and staples (mean 1.9, SD 2.5 days).
Blood loss
None of the studies reported this outcome.
Duration of catheterisation
In one trial comparing one double‐bite suture with two single‐bite sutures, the mean time of catheterisation was 2.5 days in both groups (Persson 2000).
Adverse effects
Perioperative surgical complications
In one trial comparing one double‐bite suture with two single‐bite sutures, there may be no evidence of a difference between the one‐suture and two‐suture groups in terms of perioperative surgical complications, totaling 15/78 and 14/83 in the one‐suture and two‐suture groups respectively (RR 0.88, 95% CI 0.45 to 1.70; 161 women; low‐quality evidence; Persson 2000; summary of findings Table 3).
Persson 2000 did not report bladder perforations for laparoscopic colposuspension with one suture versus two sutures.
There may be a greater risk of perioperative complications with laparoscopic colposuspension using sutures versus laparoscopic colposuspension using mesh (RR 1.94, 95% CI 1.09 to 3.48; 260 women; Ankardal 2005; Ross 1996; Zullo 2001; low‐quality evidence; summary of findings Table 4).
In two trials, there were more bladder perforations in the suture group than in the mesh group (2 versus 1 (Ankardal 2005); 4 versus 1 (Ross 1996). In one trial, there was one in each of the groups (Zullo 2001).
De novo detrusor overactivity
De novo detrusor activity was not reported for laparoscopic colposuspension with one suture versus laparoscopic colposuspension with two sutures.
There may be no evidence of a difference between laparoscopic colposuspension with sutures and laparoscopic colposuspension with mesh and sutures in the number of women with de novo detrusor overactivity (RR 0.72, 95% CI 0.17 to 3.06; 122 women; Ross 1996; Zullo 2001; low‐quality evidence; Analysis 3.4; summary of findings Table 4).
Voiding dysfunction
One trial comparing one double‐bite suture with two single‐bite sutures suggests that there may be no evidence of a difference between the groups in the numbers of women with voiding dysfunction; 1/77 and 3/81 in the one‐suture and two‐sutures groups respectively (RR 2.82, 95% CI 0.30 to 26.54; 158 women; Persson 2000; low‐quality evidence; summary of findings Table 3).
Voiding dysfunction was not reported for laparoscopic colposuspension with sutures compared with laparoscopic colposuspension with mesh and staples.
Results of subgroup analyses
Open colposuspension using sutures versus laparoscopic colposuspension using mesh and staples
Although subjective cure within 18 months seems to favour open colposuspension using sutures over laparoscopic colposuspension using mesh and staples, the quality of evidence was very low. Therefore, we are uncertain whether laparoscopic colposuspension using mesh and staples is better or worse than open colposuspension for subjective cure within 18 months (RR 0.75, 95% CI 0.61 to 0.93; 3 trials, 362 women; very low‐quality evidence; see Analysis 1.1.2).
Discussion
Summary of main results
The 26 eligible trials that we identified addressed only three of the prespecified comparisons. In particular, there were no comparisons with non‐surgical management. The three comparisons addressed by the included trials in this review are: laparoscopic colposuspension versus open colposuspension; laparoscopic colposuspension versus other minimally invasive procedures (midurethral slings); and one type of laparoscopic colposuspension versus another.
Laparoscopic colposuspension versus open colposuspension (abdominal surgery)
High‐quality evidence indicates that laparoscopic colposuspension with sutures and open colposuspension are similarly effective in terms of subjective cure of urinary incontinence at up to 18 months' follow‐up (summary of findings Table for the main comparison). However, we cannot be certain of the effectiveness of laparoscopic colposuspension with mesh and staples compared to open colposuspension as the quality of evidence is very low (summary of findings Table for the main comparison). In terms of subjective cure, we identified insufficient evidence to draw robust conclusions regarding the relative effectiveness of laparoscopic versus open colposuspension beyond 18 months after surgery.
In terms of objective cure up to 18 months after surgery, open colposuspension appears to be slightly better than laparoscopic colposuspension but beyond this point there may be little difference between the procedures. Trials collected evidence relating to quality of life using a range of validated questionnaires; these data indicated little difference between the groups but it was not possible to assess the quality of this evidence. It appears that laparoscopic colposuspension may take longer than open colposuspension but it is possible that this is offset by less blood loss, shorter inpatient stay, less catheterisation time and quicker return to daily activities. All of these are consistent with reviews of other laparoscopic operations (McCormack 2001; Sauerland 2010; Sauerland 2011).
With regard to possible harms, there is probably little difference between laparoscopic and open colposuspension in the de novo detrusor overactivity and voiding dysfunction but there may be similar or higher rates of bladder perforations with laparoscopic colposuspension (summary of findings Table for the main comparison). Laparoscopic colposuspension may reduce the risk of perioperative complications relative to open colposuspension (summary of findings Table for the main comparison). It is uncertain whether there is any difference between laparoscopic colposuspension and open colposuspension in the risk of requiring repeat continence surgery because the quality of evidence is very low (summary of findings Table for the main comparison).
Laparoscopic colposuspension versus midurethral sling procedures
Low‐quality evidence suggests there may be little difference between laparoscopic colposuspension compared with midurethral sling procedures in terms of subjective cure of urinary incontinence within 18 months after surgery, the risk of requiring repeat continence surgery, and the risk of perioperative complications and de novo detrusor overactivity (summary of findings Table 2).
There is probably little difference between laparoscopic colposuspension and midurethral slings in terms of voiding dysfunction. Trials collected evidence relating to quality of life using a range of validated questionnaires; these data indicated little difference between the groups and it was not possible to assess the quality of this evidence. Bladder perforations were not reported by the studies.
In terms of objective cure up to 18 months after surgery, laparoscopic colposuspension may be slighter better than midurethral slings. There may be little difference between the two kinds of procedure in terms of objective measures of incontinence and pain or analgesia requirements. There may however be lower rates of repeat continence surgery with laparoscopic surgery although this is based on data from one small trial. It may be that laparoscopic colposuspension requires a longer operating time, longer inpatient stay and a longer time to return to normal activity levels than midurethral sling procedures. Nevertheless, it is important to consider the possible impact of the surgical learning curve in the context of surgical outcomes.
One method of laparoscopic colposuspension against another
Low‐quality evidence suggests that laparoscopic colposuspension with two sutures may be more effective than one suture in terms of subjective cure of urinary incontinence within 18 months after surgery. However, there may be little difference between one and two sutures in terms of adverse effects or the risk of requiring repeat continence surgery, the number of perioperative complications, and voiding dysfunction (summary of findings Table 3). Trials did not report quality of life, bladder perforations or de novo detrusor activity.
We are uncertain whether there is any difference between laparoscopic colposuspension with sutures or mesh and staples in terms of subjective cure of urinary incontinence within 18 months or number requiring repeat continence surgery, as the quality of evidence was very low (summary of findings Table 4). There may be no difference between using sutures or mesh and staples in terms of number of perioperative complications and de novo detrusor overactivity (summary of findings Table 4). The trials did not report quality of life or voiding dysfunction. The limited quantity and low quality of available evidence means that we cannot be certain whether laparoscopic colposuspension with sutures or with mesh and staples is more effective in terms of other patient‐ or clinician‐reported outcomes.
Insufficient evidence means that we cannot draw any conclusions regarding the relative benefits or risks of laparoscopic colposuspension with either the transperitoneal or extraperitoneal approaches.
Brief economic commentary
A cost‐effectiveness analysis by Dumville 2006, alongside a RCT compared open colposuspension with laparoscopic colposuspension in women with SUI in the UK. Dumville 2006 conducted the cost analysis from the perspective of the UK National Health Service (NHS), and healthcare resource use data (2002 to 2003, GBP) relating to the surgery, associated hospital stay and first six months after hospital discharge were collected prospectively for each participant. The data required for the calculation of quality adjusted life years (QALYs) were collected prospectively using the EQ‐5D‐3L questionnaire at baseline, 6, 12 and 24 months. The economic evaluation was for both a six‐month and up‐to‐24‐month time horizon. Healthcare resource use over six‐month follow‐up resulted in costs of GBP 1805 for the laparoscopic arm and GBP 1433 for the open arm (differential mean cost GBP 372, 95% credibility interval (CrI) 274 to 471). At six months, QALYs were slightly higher on average in the laparoscopic arm relative to the open arm (0.005, 95% CrI −0.012 to 0.023). On average, the incremental cost per extra QALY provided by the laparoscopic approach was GBP 74,400 at six months. At 24 months, the laparoscopic arm again had higher mean QALYs compared to the open surgery group (0.04, 95% CrI −0.009 to 0.086). If the laparoscopic colposuspension did not incur any significant additional costs after six months compared with open colposuspension, then the incremental cost per extra QALY reduced to GBP 9300 at 24 months. The probability that laparoscopic colposuspension is cost‐effective was 86% when the decision maker was willing to pay up to GBP 30,000 for an additional QALY. Dumville 2006 concluded that laparoscopic colposuspension is not cost‐effective when compared with open colposuspension during the first six months but the additional QALYs might be judged to be worth the additional cost after 24‐months' follow‐up.
Valpas 2006 reported a cost‐effectiveness analysis alongside a RCT that compared laparoscopic mesh colposuspension with TVT as a primary surgical treatment in women with stress urinary incontinence over a follow‐up period of one year in Finland. The primary outcome was negative stress test and 48‐hour pad test (< 8 g/48 h) and secondary outcomes were health‐related quality of life. These were collected prospectively during the main period of hospitalisation, six weeks after surgery and after one year of follow‐up. Cost items included costs of the treatments in each treatment arm, other hospital costs and productivity costs.
Primary and secondary outcomes in the TVT group were significantly better than laparoscopic mesh colposuspension as measured by the negative stress test (60 versus 29; 95% CI for change between the groups 12.7 to 43.9), VAS (0 = no inconvenience at all; 10 = maximal inconvenience; 0.8 versus 2.4; 95% CI for change between the groups 0.65 to 2.07) and Urinary Incontinence Severity Score (UISS; 1.1 versus 2.8; 95% CI for change between the groups 0.27 to 2.94). The between‐group difference in the 48‐hour pad test did not reach statistical significance (3 versus 12.4; 95% CI for change between the groups −2.8 to 30.4; P = 0.105). The total costs per participant at one year of follow‐up for laparoscopic mesh colposuspension was EUR 3262 while TVT cost EUR 2081 (2000 EUR). Valpas 2006 concluded that when the VAS or UISS are used as the outcome measure, TVT is more cost‐effective than laparoscopic mesh colposuspension over a follow‐up period of one year (P < 0.0001).
Another cost‐effectiveness analysis compared TVT with Burch colposuspension, laparoscopic colposuspension, traditional suburethral retropubic sling procedure and injectables. Cody 2003 utilised clinical data from a systematic review of RCTs conducted up to mid‐2002 and the modelled results for a time horizon of up to 10 years. The analysis of costs and resources used was based on the UK payer's perspective (UK NHS). Based on clinical evidence, this study assumed that traditional sling effectiveness was equivalent to open colposuspension, that the effectiveness of laparoscopic colposuspension was equivalent to or possibly worse than open colposuspension (which is consistent with the findings of this review; see summary of findings Table for the main comparison), and that use of injectables was the least effective procedure. This study reported the cost (2001 GBP) to be GBP 1058 per woman with an average of 2.9 days hospital stay for TVT, GBP 1317 per woman and average hospital stay of 4.6 days for laparoscopic colposuspension, GBP 1301 per woman and average hospital stay of 7.1 days for open colposuspension, GBP 1340 per woman and average hospital stay of 7.2 days for traditional sling and GBP 1305 per woman with an average hospital stay of two days for injectables. The study concluded that TVT was more likely to be considered cost‐effective compared with the other surgical procedures based on the assumptions that traditional slings have the same effectiveness as open colposuspension and are also more costly; that laparoscopic colposuspension has the same or lower effectiveness as open colposuspension and similar costs; and that injectable agents are less effective than TVT but of greater cost.
We did not subject these identified economic evaluations to critical appraisal and we do not attempt to draw any firm or general conclusions regarding the relative costs or efficiency of laparoscopic colposuspension in treatment of stress urinary incontinence.
Overall completeness and applicability of evidence
We did not identify any relevant trials comparing laparoscopic colposuspension to non‐surgical management or to anterior vaginal repair or to traditional sling procedures. Therefore, we cannot know if laparoscopic colposuspension may be better or worse than these other treatments.
It is worth noting that 11 of 25 included trials did not report women's subjective assessment of cure of incontinence. Furthermore, the methods of measuring subjective cure and quality of life varied, which may have some effect on the applicability of our findings. The paucity of long‐term follow‐up data and the lack of standardisation in how outcomes were both measured and reported across all of the trials still means that we remain uncertain about the effectiveness of laparoscopic colposuspension beyond 18 months. In addition, we did not identify sufficient evidence about the cost‐effectiveness of laparoscopic colposuspension.
However, the trials identified here have provided evidence for some areas of clinical uncertainty. The findings presented here are based on evidence from interventions and trial populations that are largely representative of clinical practice. Furthermore, we can be confident that our comprehensive search strategies and data collection were sufficient to identify all the available evidence, notwithstanding the inherent limitations of searching bibliographic databases.
Quality of the evidence
Methodological assessment plays a crucial role in determining the quality of evidence supporting the estimated size of treatment effects of any intervention. In this review, we assessed the methodological flaws of the included trials, using the reports of the trials. Therefore, our judgement of methodological quality and hence the quality of effect estimates was influenced by the quality of reporting.
With regards to attrition bias, the rates of withdrawals and losses to follow‐up were high in some of the included trials but with small differences in rates within treatment groups. In terms of size, most of the included trials were small, meaning that a high attrition rate would result in underpowering the trials and an increased risk of type II error (false negative results). A common problem with most of the included trials was incomplete reporting, particularly with respect to the trial methods and data. Thus, we assessed some risk of bias domains 'unclear' due to incomplete reporting of methods.
The quality of evidence presented here is generally low, largely due to risk of bias attributable to suboptimal randomisation and allocation procedures and to insufficient numbers of trial participants, making the trials underpowered. Furthermore, the trials often do not present their findings transparently and with useable data. However, we identified little indication of publication bias or indirectness.
Potential biases in the review process
To reduce the risk of bias in the process of identifying relevant evidence we searched all relevant bibliographic databases with a comprehensive search strategy, broad inclusion criteria and without any language restrictions.
In this updated review, we identified outcomes for the 'Summary of findings' tables. As the review authors were already aware of the trials that were included in the previously published version of the review, it could have an impact on the outcomes selected, which could be a potential source of bias in this current update of the review.
Agreements and disagreements with other studies or reviews
Our findings relating to laparoscopic versus open colposuspension differ substantially from those of a narrative non‐systematic review of the management of urinary incontinence in women, which found laparoscopic colposuspension to be 20% less successful than open colposuspension (Thakar 2000). Furthermore, a long‐term comparative study suggested the subjective cure rates at 10 years after surgery were higher in women undergoing laparoscopic colposuspension than open colposuspension (Barr 2009).
Broadly speaking, our findings agree with the conclusions of clinical guidelines in the UK, which recommend that colposuspension (either open or laparoscopic) is offered as one of the routine procedures for stress urinary incontinence (NICE 2019). The UK guideline concludes that open and laparoscopic colposuspension are equally effective but that there may be a slightly higher risk of bladder injury with the laparoscopic approach. Our findings suggest that, overall, there is probably a similar risk of complications and adverse effects between laparoscopic and open colposuspension.
PRISMA study flow diagram: search for effectiveness studies
PRISMA study flow diagram: search for economic evaluations for the BEC
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 1 Subjective cure within 18 months.
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 2 Subjective cure from 18 months up to 5 years.
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 3 Objective cure within 18 months.
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 4 Objective cure from 18 months up to 5 years.
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 5 Objective cure after 5 years.
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 6 Length of inpatient stay (days).
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 7 Time to return to daily activities (days).
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 8 Operation time (minutes).
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 9 Blood loss (mL).
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 10 Duration of catheterisation (days).
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 11 Perioperative complications (number of events).
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 12 Bladder perforations.
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 13 De novo detrusor overactivity (urodynamic diagnosis).
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 14 Voiding dysfunction within 18 months.
Comparison 1 Laparoscopic colposuspension versus open colposuspension, Outcome 15 Quality of life.
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 1 Subjective cure within 18 months.
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 2 Number of women with de novo urgency symptoms.
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 3 Incontinence episodes per week.
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 4 Objective cure within 18 months.
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 5 Length of inpatient stay (days).
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 6 Time to return to daily activities (days).
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 7 Operation time (mins).
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 8 Perioperative complications (number of events).
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 9 De novo detrusor overactivity (urodynamic diagnosis) within 18 months.
Comparison 2 Laparoscopic colposuspension versus midurethral sling procedures, Outcome 10 Voiding dysfunction within 18 months.
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 1 Subjective cure within 18 months.
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 2 Objective cure within 18 months.
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 3 Perioperative complications.
Comparison 3 Laparoscopic colposuspension with sutures versus laparoscopic colposuspension with mesh and staples, Outcome 4 De novo detrusor overactivity within 18 months.
| Laparoscopic colposuspension compared to open colposuspension for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with open colposuspension | Risk with laparoscopic colposuspension | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using sutures | Study population | RR 1.04 | 755 | ⊕⊕⊕⊕ | ||
| 789 per 1000 | 821 per 1000 | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using mesh and staples | Study population | RR 0.75 | 362 | ⊕⊝⊝⊝ | ||
| 906 per 1000 | 679 per 1000 | |||||
| Quality of life | ‐ | ‐ | 742 | ‐ | Trials collected QoL evidence using a range of validated questionnaires. Data were unsuitable for synthesis and indicated little evidence of a difference between the groups. | |
| Repeat continence surgery: | 60 | At 5 years 3/30 in the laparoscopic colposuspension group and 0/30 in the open colposuspension group had repeat continence surgery. | ||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 0.67 | 1369 | ⊕⊕⊝⊝ | ||
| 174 per 1000 | 117 per 1000 | |||||
| Adverse effects: bladder perforations | Study population | RR 1.72 | 1311 | ⊕⊕⊕⊝ | ||
| 18 per 1000 | 30 per 1000 | |||||
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) | Study population | RR 1.29 | 472 | ⊕⊕⊕⊝ | ||
| 75 per 1000 | 96 per 1000 | |||||
| Adverse effects: voiding dysfunction | Study population | RR 0.81 | 507 | ⊕⊕⊕⊝ | ||
| 109 per 1000 | 88 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to unclear risk of selection bias. | ||||||
| Laparoscopic colposuspension compared to midurethral sling procedures for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with midurethral sling procedures | Risk with laparoscopic colposuspension | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using sutures versus TVT | Study population | RR 1.01 | 256 | ⊕⊕⊝⊝ | ||
| 741 per 1000 | 748 per 1000 | |||||
| Subjective cure within 18 months: laparoscopic colposuspension using mesh versus TVT | Study population | RR 0.71 | 121 | ⊕⊕⊝⊝ | ||
| 829 per 1000 | 588 per 1000 | |||||
| Quality of life | ‐ | ‐ | 385 | ‐ | Trials collected QoL evidence using a range of validated questionnaires. Data were unsuitable for synthesis and indicated little evidence of a difference between the groups. | |
| Repeat continence surgery: | 1/32 women in the laparoscopic colposuspension group and 3/38 women in the midurethral slings group had repeat continence surgery. | RR 0.40 | 70 | ⊕⊕⊝⊝ | ||
| 79 per 1000 | 32 per 1000 | |||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 0.99 | 514 | ⊕⊕⊝⊝ | ||
| 99 per 1000 | 98 per 1000 | |||||
| Adverse effects: bladder perforations | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported. |
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) | Study population | RR 0.80 | 326 | ⊕⊕⊝⊝ | ||
| 62 per 1000 | 50 per 1000 | |||||
| Adverse effects: voiding dysfunction | Study population | RR 1.06 | 412 | ⊕⊕⊕⊝ | ||
| 41 per 1000 | 44 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to unclear risk of bias in most domains. | ||||||
| Laparoscopic colposuspension with one suture compared to laparoscopic colposuspension with two sutures for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with laparoscopic colposuspension with two sutures | Risk with laparoscopic colposuspension with one suture | |||||
| Subjective cure within 18 months | Study population | RR 1.37 | 158 | ⊕⊕⊝⊝ | ||
| 889 per 1000 | 1000 per 1000 | |||||
| Quality of life | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Repeat continence surgery: | 1/80 women in the two‐suture group and 0/77 women in the one‐suture group had repeat continence surgery. | RR 0.35 | 157 | ⊕⊕⊝⊝ | ||
| 13 per 1000 | 4 per 1000 | |||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 0.88 | 161 | ⊕⊕⊝⊝ | ||
| 169 per 1000 | 148 per 1000 | |||||
| Adverse effects: bladder perforations | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) Follow‐up: 18 months | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Adverse effects: voiding dysfunction | Study population | RR 2.82 | 158 | ⊕⊕⊝⊝ | ||
| 37 per 1000 | 104 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to serious imprecision: one single small trial and wide CIs indicating possibility of benefit or harm in either direction. | ||||||
| Laparoscopic colposuspension with sutures compared to laparoscopic colposuspension with mesh and staples for urinary incontinence in women | ||||||
| Patient or population: women with urinary incontinence | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with laparoscopic colposuspension with mesh and staples | Risk with laparoscopic colposuspension with sutures | |||||
| Subjective cure within 18 months | Study population | RR 1.24 | 180 | ⊕⊝⊝⊝ | ||
| 696 per 1000 | 863 per 1000 | |||||
| Quality of life | ‐ | ‐ | ‐ | Not reported | ||
| Repeat continence surgery: follow‐up 1 year | 1/35 in the sutures group and 1/34 in the mesh group had repeat continence surgery. | RR 0.97 | 69 | ⊕⊝⊝⊝ | ||
| 29 per 1000 | 29 per 1000 | |||||
| Adverse effects: perioperative complications (number of events) | Study population | RR 1.94 | 260 | ⊕⊕⊝⊝ | ||
| 114 per 1000 | 221 per 1000 | |||||
| Adverse effects: bladder perforations | ‐ | ‐ | ‐ | ‐ | ‐ | In two trials (Ankardal 2005; Ross 1996), there were more (2 and 4, respectively) bladder perforations in the suture group than in the mesh group (1 perforation). In one trial (Zullo 2001), there was one in each of the groups. |
| Adverse effects: de novo detrusor overactivity (urodynamic diagnosis) | Study population | RR 0.72 | 122 | ⊕⊕⊝⊝ | ||
| 67 per 1000 | 48 per 1000 | |||||
| Adverse effects: voiding dysfunction | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded one level due to unclear risk of selection, performance and detection bias. | ||||||
| Laparoscopic colposuspension versus open colposuspension | |||
| Study | Outcome | Laparoscopic | Open |
| VAS scores (median, range): Physical activity Working ability Social life Sexual life | 1 (0‐47) 0 (0‐13) 0 (0‐20) 0 (0‐10) | 0 (0‐4) 0 (0‐0) 0 (0‐0) 0 (0‐0) | |
| VAS scores (median, range): Physical activity Working ability Social life Sexual life | (mesh) 2 (0‐44) 0 (0‐16) 0 (0‐20) 0 (0‐18) | 0 (0‐2) 0 (0‐0) 0 (0‐0) 0 (0‐0) | |
| VAS scores (median, range): Physical activity Working ability Social life Sexual life | (sutures) 0 (0‐0) 0 (0‐0) 0 (0‐0) 0 (0‐0) | 0 (0‐2) 0 (0‐0) 0 (0‐0) 0 (0‐0) | |
| SF‐36 General Health (mean, SD)a | 2.60 (1.02) | 2.22 (1.06) | |
| SUDI (mean, SD)b | 23.92 (17.90) | 21.56 (16.92) | |
| SIIQb | 31.40 (23.83) | 26.87 (29.36) | |
| VAS scores (mean, SD): Return to normal activity (days) | 22.2 (15.9) | 29.3 (19.8) | |
| SF‐36 (mean, SD): physical subscalea SF‐36 (mean, SD): mental subscalea | 79.32 (27.59) 69.51 (21.21) | 77.60 (27.74) 69.38 (22.65) | |
| EQ‐5D (mean, SD)b | 0.844 (0.259) | 0.825 (0.270) | |
| Mean (SD) total costs | GBP 1805 (471) | GBP 1433 (362) | |
| QALYs at 2 years (mean) | 1.677 | 1.637 | |
| EQ‐5D: EuroQuol generic health questionnaire; QALY: quality‐adjusted life years; SD: standard deviation; SF‐36: short‐form 36 item health survey; SIIQ: Short Incontinence Impact Questionnaire; SUDI: Short Urinary Distress Inventory; VAS: visual analogue scale | |||
| aHigher score = greater quality of life. | |||
| Study | Outcome | Laparoscopic colposuspension | Midurethral slings |
| Quality of life | |||
| YQ and UDI | No evidence of a difference between groups | ||
| SUDI, SIIQ, SF‐36 | No evidence of a difference between groups | ||
| SF‐36 to assess quality of life. Symptom distress for urinary incontinence in women with the IIQ and the UDI | No evidence of a difference between groups | ||
| UDI‐6 and IIQ‐7 | No evidence of a difference between groups | ||
| SUDI, SIIQ, SF‐36 | No significant difference between the two groups | ||
| SF‐36 to assess quality of life. Symptom distress for urinary incontinence in women with the IIQ and the UDI | No evidence of a difference between groups | ||
| UDI‐6 and IIQ‐7 | No evidence of a difference between groups | ||
| I‐QOL, UDI‐6 and ISI | I‐QOL: "significantly increased in both groups after 6 months of operation (p<0.05). But the differences were not statistically significant". UDI‐6: improvement in urgency was significant in TOT compared to Burch (P = 0.04) ISI: subjective cure rate following surgery showing no evidence of a difference between groups (P = 0.23) | ||
| Womens' observations | |||
| PGII at 1 year Procedure met woman’s expectation
Would recommend to a friend
PGII at 3 years Procedure met woman’s expectation
Would recommend to a friend
PGII at 5 years Procedure met woman’s expectation
Would recommend to a friend
| 58.8% 27.5% 7.8% 74.5% 15.7% 3.9% 64.7% 21.6% 5.9% 76.5% 9.8% 3.9% 51.0% 23.5% 3.9% 66.7% 7.8% 5.9% | 82.9% 11.4% 0% 92.9% 1.4% 0% 71.4% 7.1% 0% 77.1% 2.9% 0% 64.3% 8.6% 0% 67.1% 23.5% 3.9% | |
| UISSa (0–20; mean, SD at 5 years) | 3.4 (4.0) | 1.8 (3.4) | |
| Surgical costs | |||
| AUD 3388 | AUD 3633 | ||
| lap USD 6368 | USD 6059 | ||
| EUR 1273.40 | EUR 1342.80 | ||
| EUR 1342.80 | EUR 1180.10 | ||
| Mean duration of catheterisation | |||
| 2.7 days (2.6) | 1.4 days (2.1) | ||
| lap 4.9 days | 5.2 days | ||
| 3 days (range 1‐5) | 1 days (range 0‐7) | ||
| 24.4 h | 9.2 h | ||
| IIQ: Incontinence Impact Questionnaire;ISI: Incontinence Symptom Index; I‐QOL: Incontinence Quality of Life; PGII: Patients' Global Impression of Improvement; SD: standard deviation; SF‐36: short‐form 36 item health survey; SIIQ: Short Incontinence Impact Questionnaire; SUDI: Short Urinary Distress Inventory; UDI: Urogenital Distress Inventory; UISS: Urinary Incontinence Severity Score; YQ: York Quality of life | |||
| aLower score = greater quality of life. | |||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Subjective cure within 18 months Show forest plot | 8 | 1117 | Risk Ratio (M‐H, Random, 95% CI) | 0.92 [0.81, 1.05] |
| 1.1 Laparoscopic colposuspension using sutures | 6 | 755 | Risk Ratio (M‐H, Random, 95% CI) | 1.04 [0.99, 1.08] |
| 1.2 Laparoscopic colposuspension using mesh and staples | 3 | 362 | Risk Ratio (M‐H, Random, 95% CI) | 0.75 [0.61, 0.93] |
| 2 Subjective cure from 18 months up to 5 years Show forest plot | 2 | 323 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.94 [0.77, 1.14] |
| 2.1 Laparoscopic colposuspension using sutures | 1 | 263 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.81, 1.25] |
| 2.2 Laparoscopic colposuspension using mesh and staples | 1 | 60 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.71 [0.47, 1.08] |
| 3 Objective cure within 18 months Show forest plot | 9 | 1117 | Risk Ratio (M‐H, Random, 95% CI) | 0.94 [0.86, 1.02] |
| 3.1 Laparoscopic colposuspension using sutures | 8 | 830 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.89, 1.06] |
| 3.2 Laparoscopic colposuspension using mesh and staples | 2 | 287 | Risk Ratio (M‐H, Random, 95% CI) | 0.81 [0.72, 0.91] |
| 4 Objective cure from 18 months up to 5 years Show forest plot | 2 | 290 | Risk Ratio (M‐H, Random, 95% CI) | 0.82 [0.41, 1.63] |
| 4.1 Laparoscopic colposuspension using sutures | 2 | 290 | Risk Ratio (M‐H, Random, 95% CI) | 0.82 [0.41, 1.63] |
| 5 Objective cure after 5 years Show forest plot | 2 | 107 | Risk Ratio (M‐H, Random, 95% CI) | 0.89 [0.28, 2.80] |
| 6 Length of inpatient stay (days) Show forest plot | 8 | 1142 | Mean Difference (IV, Random, 95% CI) | ‐1.20 [‐1.84, ‐0.56] |
| 7 Time to return to daily activities (days) Show forest plot | 4 | 401 | Mean Difference (IV, Random, 95% CI) | ‐14.27 [‐25.17, ‐3.38] |
| 8 Operation time (minutes) Show forest plot | 7 | 928 | Mean Difference (IV, Random, 95% CI) | 21.80 [10.59, 33.01] |
| 8.1 Laparoscopic colposuspension using sutures | 5 | 549 | Mean Difference (IV, Random, 95% CI) | 25.27 [6.21, 44.33] |
| 8.2 Laparoscopic colposuspension using mesh and staples | 3 | 379 | Mean Difference (IV, Random, 95% CI) | 16.77 [6.59, 26.95] |
| 9 Blood loss (mL) Show forest plot | 9 | 940 | Mean Difference (IV, Random, 95% CI) | ‐87.64 [‐141.70, ‐33.58] |
| 10 Duration of catheterisation (days) Show forest plot | 4 | 449 | Mean Difference (IV, Random, 95% CI) | ‐2.39 [‐3.48, ‐1.30] |
| 11 Perioperative complications (number of events) Show forest plot | 11 | 1369 | Risk Ratio (M‐H, Random, 95% CI) | 0.67 [0.47, 0.94] |
| 11.1 Laparoscopic colposuspension using sutures | 9 | 1003 | Risk Ratio (M‐H, Random, 95% CI) | 0.71 [0.57, 0.89] |
| 11.2 Laparoscopic colposuspension using mesh and staples | 3 | 366 | Risk Ratio (M‐H, Random, 95% CI) | 0.54 [0.20, 1.46] |
| 12 Bladder perforations Show forest plot | 10 | 1311 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.72 [0.90, 3.29] |
| 12.1 Laparoscopic colposuspension using sutures | 8 | 957 | Risk Ratio (M‐H, Fixed, 95% CI) | 2.15 [0.97, 4.77] |
| 12.2 Laparoscopic colposuspension using mesh and staples | 3 | 354 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.30, 3.25] |
| 13 De novo detrusor overactivity (urodynamic diagnosis) Show forest plot | 6 | Risk Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
| 13.1 Within 18 months | 5 | 472 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.29 [0.72, 2.30] |
| 13.2 Between 18 months and 5 years | 1 | 50 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.0 [0.07, 15.12] |
| 13.3 After 5 years | 2 | 107 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.22 [0.40, 3.75] |
| 14 Voiding dysfunction within 18 months Show forest plot | 5 | 507 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.50, 1.31] |
| 15 Quality of life Show forest plot | 2 | Std. Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 15.1 EQ‐5D and SUDI | 2 | 491 | Std. Mean Difference (IV, Random, 95% CI) | 0.10 [‐0.08, 0.27] |
| 15.2 EQ‐5D and SIIQ | 2 | 491 | Std. Mean Difference (IV, Random, 95% CI) | 0.11 [‐0.07, 0.29] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Subjective cure within 18 months Show forest plot | 5 | 377 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.91 [0.80, 1.02] |
| 1.1 Laparoscopic colposuspension using sutures vs TVT | 4 | 256 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.01 [0.88, 1.16] |
| 1.2 Laparoscopic colposuspension using mesh vs TVT | 1 | 121 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.71 [0.55, 0.91] |
| 2 Number of women with de novo urgency symptoms Show forest plot | 2 | 201 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.44 [0.13, 1.47] |
| 3 Incontinence episodes per week Show forest plot | 2 | 150 | Mean Difference (IV, Fixed, 95% CI) | ‐1.40 [‐2.07, ‐0.73] |
| 3.1 Laparoscopic colposuspension using sutures vs TVT | 1 | 63 | Mean Difference (IV, Fixed, 95% CI) | ‐1.4 [‐3.30, 0.50] |
| 3.2 Laparoscopic colposuspension using sutures vs SPARC sling | 1 | 87 | Mean Difference (IV, Fixed, 95% CI) | ‐1.4 [‐2.12, ‐0.68] |
| 4 Objective cure within 18 months Show forest plot | 7 | 575 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.88 [0.81, 0.95] |
| 4.1 Laparoscopic colposuspension using sutures vs TVT | 6 | 454 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.93 [0.86, 1.01] |
| 4.2 Laparoscopic colposuspension using mesh vs TVT | 1 | 121 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.66 [0.51, 0.86] |
| 5 Length of inpatient stay (days) Show forest plot | 5 | 322 | Mean Difference (IV, Fixed, 95% CI) | 1.18 [0.82, 1.55] |
| 6 Time to return to daily activities (days) Show forest plot | 3 | 280 | Mean Difference (IV, Fixed, 95% CI) | 7.14 [4.60, 9.67] |
| 7 Operation time (mins) Show forest plot | 6 | 392 | Mean Difference (IV, Random, 95% CI) | 25.85 [13.56, 38.13] |
| 8 Perioperative complications (number of events) Show forest plot | 7 | 514 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.99 [0.60, 1.64] |
| 8.1 Laparoscopic colposuspension using sutures vs TVT | 6 | 393 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.46, 1.45] |
| 8.2 Laparoscopic colposuspension using mesh vs TVT | 1 | 121 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.92 [0.65, 5.71] |
| 9 De novo detrusor overactivity (urodynamic diagnosis) within 18 months Show forest plot | 4 | 326 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.34, 1.88] |
| 9.1 Laparoscopic colposuspension using sutures vs TVT | 4 | 326 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.34, 1.88] |
| 10 Voiding dysfunction within 18 months Show forest plot | 5 | 412 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.06 [0.47, 2.41] |
| 10.1 Laparoscopic colposuspension using sutures vs TVT | 4 | 291 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.41, 2.48] |
| 10.2 Laparoscopic colposuspension using mesh vs TVT | 1 | 121 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.37 [0.20, 9.42] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Subjective cure within 18 months Show forest plot | 2 | 180 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.28 [1.11, 1.47] |
| 2 Objective cure within 18 months Show forest plot | 3 | 243 | Risk Ratio (M‐H, Random, 95% CI) | 1.17 [0.89, 1.55] |
| 3 Perioperative complications Show forest plot | 3 | 260 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.94 [1.09, 3.48] |
| 4 De novo detrusor overactivity within 18 months Show forest plot | 2 | 122 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.72 [0.17, 3.06] |
