Introduction
Methods
Protocol and registration
Identification and selection of studies
Inclusion and exclusion criteria
Inclusion criteria | Exclusion criteria | |
---|---|---|
Study design, comparison | Any quantitative study type of primary research with exception of case studies/case series < 10 participants; retrospective studies are included | Reviews, cross-sectional studies, case reports/case series < 10 participants, conference papers and abstracts, book chapters, editorials |
Control interventions may include treatment as usual, no treatment, surgery, medicinal treatment, physical therapy modalities or placebo treatment | Unconcluded studies, studies with missing outcome data | |
Studies that were published in languages other than English and German | ||
Participants | People with chronic pelvic pain according to the guidelines on chronic pelvic pain [2] including constipation (conditions with overactive pelvic floor dysfunction) | Pelvic organ prolapse, fecal or urinary incontinence (hypotonic pelvic floor dysfunction) |
People with acute pelvic pain | ||
Males and females | ||
Children, adolescents, adults | ||
Interventions | Biofeedback as a sole intervention or as a significant component of a multimodal intervention | No BFB-assisted training performed/BFB was not a relevant component of the treatment |
Clinical (in/outpatient) setting or home-based training | If only a subgroup of the study population received BFB: studies were excluded if the number of subjects in the BFB subgroup or the outcome results of this subgroup were not stated | |
Insufficiently documented BFB intervention: no information on the training extent (frequency, number of sessions or duration of a single session) or the mode of application | ||
Outcome measures | Primary outcome: – Pain intensity – Overall symptom improvement – Quality of life | – |
Secondary outcome: – Physiological parameters, indicative of pelvic floor muscle tone or general relaxation |
Data collection and analysis
Study | Country | Study design (details: see Table 8) | n of IG receiving BFB (n of whole study participants) | Drop-outs at last f/u/excluded from analysis | Diagnose(s), symptoms: | Conclusions by authors of respective papers |
---|---|---|---|---|---|---|
Anorectal pain syndrome | ||||||
Chiarioni et al. 2010 [16] | Italy | RCT (3 arm): 3 different interventions compared | 52 (157) | n.a. | Levator ani syndrome (constipation excluded) | BFB is superior to EGS and levator ani massage in pain relief. Improvements maintained for 12 months. Only patients with tenderness on rectal examination benefit. Pathophysiology of levator ani syndrome pathophysiology is similar to dyssynergic defecation type constipation |
Heah et al. 1997 [17] | Singapore | Non-RCT, single-group (prospective) | 16 (16) | 0/16 (post treatment); n.a. (later f/u) | Levator ani syndrome | Although BFB had a negligible effect on anorectal physiologic measurements, it was effective in pain relief, with no side effects |
Ger et al. 1993 [18] | USA | Non-RCT, 3 arm, non-randomized (prospective) | 14 (60) | 22/60 | Chronic intractable rectal pain ± coccygodynia ± constipation/dyschezia (n = 34/60) | BFB vs. EGS vs. epidural steroid caudal block: EGS and BFB had almost the same poor results (>50% were refractory); No significant differences in rates of success or failure after any of the 3 therapeutic options, regardless of whether the option was a primary, secondary, or tertiary choice. Associated historic factors or abnormalities in anorectal physiologic studies did not influence results |
Gilliland et al. 1997a [19] | USA | Non-RCT (retrospective) | 86 (86) | 11/86 | Chronic intractable rectal pain ± constipation (n = 30/86) | EMG-based BFB can produce alleviation of idiopathic rectal pain. Outcome was significantly improved in patients who completed the treatment schedule compared to those who self-discharged. Outcome was not influenced by patients’ ages, duration of symptoms or prior history of surgery and was not significantly related to the presence of paradoxical puborectalis contraction (EMG or defecography) |
Grimaud et al. 1991 [20] | France | Non-RCT, single-group (prospective) + cross-sectional | 12 (24) 12 healthy | 0/12 | Chronic idiopathic anal pain ± constipation (n = 9/12) | Chronic idiopathic anal pain is associated with abnormal anorectal manometric profiles (↑ anal canal resting pressure), probably resulting from a dysfunctioning of the striated external anal sphincter. BFB is an effective treatment for chronic idiopathic anal pain. Anorectal pain disappeared after a mean of 8 BFB sessions |
Constipation, dyssynergic defecation | ||||||
Chiarioni et al. 2006 [21] | Italy | RCT (2 arm: intervention vs. different intervention) | 54 (109) | 14/109 (10/54 in BFB group) | Normal transit constipation due to PFD (Rome II criteria) | 5 × 30min BFB sessions are more effective than continuous polyethylene glycol in PF dyssynergia (major improvement in 80%), benefits last at least 2 years. BFB should become the treatment of choice PFD. Predictors of better response to BFB: sensation of incomplete or blocked evacuation, straining with bowel movements; predictors of poorer response: digital facilitation of defecation |
Koutsomanis et al. 1994 [22] | Italy | Non-RCT, single-group (prospective) | 54 (109) | 10/30 | Idiopathic constipation | ~50% of patients were helped by 2–6 BFB sessions, improvement persisted for ≥ 6–12 months. Both types of PF incoordination (inability to relax on defecation and inability to strain effectively) improved. No clear correlation between change in transit rate and symptomatic outcome |
Chiotakakou-Faliakou et al. 1998 [23] | UK | Non-RCT (retrospective) | 30 (30) | 0/100 | Chronic idiopathic slow and normal transit constipation | BFB is an effective long-term treatment for the majority of patients with idiopathic constipation unresponsive to traditional treatment (>50% improved). Patients with slow/normal transit, males/females, with/without paradoxical PF contraction benefited equally. Anorectal testing did not predict outcome |
Battaglia et al. 2004 [24] | UK | Non-RCT, single-group (prospective) | 100 (100) | n.a. | Chronic constipation (Rome II criteria) | Patients with PFD are likely to have continued benefit from BFB, whereas its effects on slow-transit constipation seems to be maximal in short-term course. Anorectal manometric variables remained unchanged (apart from sensation threshold ↓ in PFD group, maximum rectal tolerable volume ↓ in slow-transit group) |
Wang et al. 2003 [25] | Italy | Non-RCT, single-group (prospective) | 24 (24) | n.a. | Chronic idiopathic constipation (Rome II criteria) | BFB has a long-term effect with no side effects for most patients (62.5%) with chronic idiopathic constipation unresponsive to traditional treatment. Patients with slow/normal transit, with/without paradoxical PF contraction benefited equally. The psychological status rather than anorectal test could predict outcome. The efficacy of the two modes of BFB was similar |
Ba-Bai-Ke-Re et al. 2014 [26] | China | RCT (2 arm: 2 different interventions) | 50 (50) | 0/44 | Chronic obstructive constipation (Rome III criteria) | Manometric BFB-guided PF exercise is superior to oral polyethylene glycol for obstructive defecation for improving overall symptoms, pain at defecation, quality of life |
Roy et al. 2000 [27] | China | Non-RCT (retrospective) | 44 (88) | n.a. | Chronic idiopathic constipation (no surgery: n = 25/78, hysterectomy and no change in bowel function: n = 27/78, hysterectomy subjectively led to constipation: n = 26/78) | The majority of patients complaining of constipation induced by hysterectomy subjectively respond to behavioral treatment, in a similar proportion to those with idiopathic constipation. Physiological testing did not predict outcome |
Chiarioni et al. 2005 [28] | UK | Non-RCT, single group (prospective) | 78 (78) | 7/52 | Chronic idiopathic constipation (PFD: n = 34/52, slow transit only: n = 12/52, 1–2 criteria for PFD: n = 6/52) | BFB is an effective treatment for PFD but not slow-transit constipation. Improvements were maintained at f/u 24 months. BFB eliminated dyssynergia in 91% and enabled 85% to defecate the balloon. Success was predicted by PFD, milder constipation, and less frequent abdominal pain at baseline |
Zhu et al. 2011 [29] | Italy | Non-RCT single group, observational | 41 (41) | 5/41 | Functional constipation with PFD (Rome III criteria) | Before treatment, 7 Short Form-36 subscales (except bodily pain) were significantly lower in people with PFD than in healthy individuals. After BFB, all subcategories except general health showed improvement surpassing pretreatment baseline values and equalling those for normal. The total Patient Assessment of Constipation Quality of Life Questionnaire score also dramatically improved as did all subscales |
Gilliland et al. 1997b [30] | USA | Non-RCT (retrospective) | 194 (194) | 16/194 | Chronic constipation ± concomitant rectal pain (n = 30/194) | Success rate of BFB for constipated patients is less than previously reported (35% complete success, 13% partial success). Success rate ↑ after ≥ 5 sessions and was significantly related to patient’s willingness to complete treatment and number of sessions attended. Neither patient age, sex, abnormalities in manometry nor duration of symptoms significantly affected outcome |
Parker et al. 2019 [31] | Canada | Non-RCT (retrospective) | 130 (130) | 38/168 | Chronic constipation + PFD (n = 53/130), without PFD (n = 3/130), fecal incontinence (n = 49/130), constipation + fecal incontinence (n = 22/130), rectal pain (n = 3/130) | In patients with chronic constipation due to PFD, overall response rate was 69.8%, only 45.3% had symptomatic improvement. These patients are less likely to have symptomatic response than those with fecal incontinence. 3 BFB sessions are insufficient to manage dyssynergic defecation |
Male chronic pelvic pain syndrome, urological chronic pelvic pain syndrome | ||||||
Clemens et al. 2000 [32] | – | Non-RCT, single group | 19 (19) | 3/19 | Nonbacterial male CPPS [33] (NIH type IIIA prostatitis: n = 6/19, NIH type IIIB prostatitis: n = 13/19) | A formalized program of neuromuscular reeducation of PF muscles with interval bladder training can provide significant, durable improvement in objective measures of pain, urgency, and frequency in patients with CPPS. Detrusor instability, hypersensitivity to filling, or bladder-sphincter pseudodyssynergia on pretreatment urodynamic studies were not predictive of treatment results |
Cornel et al. 2005 [34] | USA | Non-RCT, single group; observational | 33 (33) | 2/33 (15/33 for EMG values) | Male CPPS (NIH type III prostatitis) [33] | BFB physical therapy and PF reeducation lead to a significant symptom improvement and decrease of PF muscle tonus |
Yang et al. 2017 [35] | Netherlands | Non-RCT (retrospective) | 22 (50) | 5/50 | Male CPPS (NIH type IIIA, IIIB prostatitis) [33] | Both electromagnetic stimulation and EGS + BFB physical therapy of PF muscle effectively reduce pain, increase quality of life and improve urinary tract symptoms in refractory male CPPS. EGS + BFB had additional benefits on pain and QoL compared to electromagnetic stimulation alone |
He et al. 2010 [36] | Taiwan | Non-RCT (retrospective) | 21 (21) | n.a. | Nonbacterial male CPPS + dysfunctional voiding | BFB had satisfactory short-term effects on patients with dysfunctional voiding and chronic prostatitis. Urodynamics could be used to help in the diagnosis and select the most appropriate treatment |
Female chronic pelvic pain | ||||||
Schmitt et al. 2017 [37] | USA | Non-RCT, single-group (prospective) | 94 (94) | Pelvic pain or dyspareunia (n = 29/94), defecatory smptoms (n = 31/94), urinary symptoms (n = 84/94) | An aggressive PF rehabilitation program including BFB with vaginal EGS had a high rate of self-reported subjective success and satisfaction in patients with PF dysfunction | |
Glazer et al. 1995 [38] | USA | Non-RCT, single-group (prospective) | 33 (33) | n.a. | Vulvar vestibulitis syndrome | PF muscle instability is a critical factor in pain associated with vulvar vestibulitis syndrome. A BFB-assisted exercise program that stabilizes PF muscles significantly reduces and, in some cases, eliminates symptoms. The more the PF muscle stabilized, the more pain decreased, the higher the initial pain, the higher the pain reduction. 6‑month f/u indicated maintenance of therapeutic benefits |
McKay et al. 2001 [39] | USA | Non-RCT, single-group (prospective) | 29 (29) | Monthly f/u, 25/29 (!) after 11 months | Moderate—severe vulvar vestibulitis syndrome | EMG BFB of PF is an effective approach to vulvar vestibulitis. 88.9% reported negligible or mild pain after treatment |
Gentilcore-Saulnier et al. 2010 [40] | Canada | Non-RCT, single-group (prospective) + cross-sectional | 11 (22) | n.a. | Provoked vestibulodynia ± constipation, dysmenorrhea, urinary frequency | Women with provoked vestibulodynia showed altered PF muscle behavior compared to controls, providing empirical evidence of PF muscle dysfunction, especially at the superficial layer. A physiotherapy rehabilitation program targeting PF muscle dysfunction normalized PF muscle behavior |
Bendana et al. 2009 [41] | USA | Non-RCT (retrospective) | 52 (52) | 0/52 dropoutsa | Painful PF spasm + urinary urgency/frequency | Combined transvaginal BFB, electrostimulation and behavioral therapy targeting PF relaxation demonstrated statistically significant improvement in urinary symptoms for up to 3 months. Further study for refractory patients is warranted |
Philips et al. 1992 [42] | Canada | RCT (randomized yoked design, intervention vs. different vs. no intervention) | 10 (30) | n.a. | Urethral syndrome + functional urinary incoordination (pelvic pain: n = 11/30, dyspareunia: n = 9/30) | Both EMG BFB and progressive muscle relaxation proved effective in improving symptomology and psychological state in patients with functional urinary incoordination |
Hart et al. 1981 [43] | USA | Non-RCT, 2 arm: 2 different interventions (prospective) | 14 (14) | 3/14 | Spasmodic dysmenorrhea according to MSQ | BFB and temperature training are effective in reducing many of the painful symptoms of primary dysmenorrhea. There was no significant difference between EMG and temperature training |
Bennink et al. 1982 [44] | USA | RCT (3 arm: intervention ± different intervention vs. no intervention) | 5 (15) | 0/15 | Primary dysmenorrhea (spasmodic or congestive) | Subjective reports indicated that the symptoms of dysmenorrhea improved for the BFB group but not for the relaxation or control groups |
Vagedes et al. 2019 [45] | Germany | RCT (3 arm: 2 different interventions vs. standard care) | 20 (60) | 12/60 (6/20 in BFB group) | Primary dysmenorrhea | Preliminary evidence suggests that rhythmical massage might improve pain intensity after 12 weeks compared to usual care. No significant differences were found between heart rate variability-based home-BFB and the control group |
Starr et al. 2013 [46] | USA | Non-RCT (retrospective) | 778 (778) | 97/778 | PF dysfunction (urinary: n = 694/778, defecatory: n = 187/778, pelvic pain: n = 368/778) | Comprehensive PF rehabilitation including PF muscle training, BFB, EGS, constipation management, behavioral modification, incontinence devices, and pharmacotherapy is effective in treating women with PF dysfunction |
Lúcio et al. 2014 [47] | Brazil | RCT, (3 arm: multimodal + sham vs. local vs. distal electrotherapy) | 30 (30) | 10/30 | Woman with multiple sclerosis + sexual dysfunction | PF muscle training with EMG BFB—alone or combined with intravaginal EGS or transcutaneous tibial nerve stimulation—contributes to the improvement of sexual dysfunction in patients with multiple sclerosis |
Aalaie et al. 2020 [48] | Iran | RCT (2 arm: 2 different interventions) | 11 (22) | 1/22 (in BFB group) | Both BFB and EGS increased the FSFI score. Both interventions decreased pain during vaginal penetration similarly. To improve sexual function, women undergoing BFB seem to benefit more than those receiving EGS | |
Chronic pelvic pain in children | ||||||
Hoebeke et al. 2004 [51] | Belgium | Non-RCT, single-group (prospective) | 21 (21) | n.a. | PF spasms ± detrusor hyperactivity (n = 13/21), ±dysfunctional voiding (n = 5/21), ±constipation (n = 8/21) | Pelvic floor spasms in children (which can be secondary to detrusor overactivity) respond well to pelvic floor relaxation therapy |
Ebiloglu et al. 2016 [52] | Turkey | Non-RCT (retrospective) | 136 (136) | n.a. | Overactive bladder syndrome | BFB can be thought of as the first-line treatment option when standard urotherapy fails. Success rate was 53% for urgency, 69% for dysuria. The mean LUTSS significantly improved after BFB. Patients without holding maneuvers, daytime incontinence and enuresis had better recovery compared to the opposites |
Ergin et al. 2016 [53] | Turkey | Non-RCT, single-group (prospective) + cross-sectional | 52 (100) 48 healthy | 13/52 | Dysfunctional voiding (n = 52/100), +overactive bladder syndrome (n = 27/52) | Urinary nerve growth factor (UNGF) Ievels were higher in children with dysfunctional voiding and decreased after BFB. UNGF Ievels could be used for the diagnosis and the assessment of BFB success in these children |
Li et al. 2006 [54] | China | Non-RCT, single-group (prospective) + cross-sectional | 25 (40) 15 healthy | 0/25 | Pubertal chronic prostatitis, NIH type II (n = 1/25), IIIA (n = 3/25), IIIB (n = 21/25) | The main type of chronic prostatitis during puberty is IIIB; the dominating symptom is a voiding disorder. The impact on life and psychological effects are substantial. Pubertal boys with chronic prostatitis have PF dysfunction and several abnormal urodynamic values. The effect of BFB in pubertal chronic prostatitis is satisfactory |
Musculoskeletal, low back pain, myofascial pain | ||||||
Kent et al. 2015 [55] | Denmark | RCT (2 arm: intervention + standard care vs. placebo + standard care) | 58 (112) | 19/112 | Subacute—chronic low back pain | Individualized movement retraining using motion-sensor biofeedback resulted in significant and sustained improvements in low back pain. This pilot trial also refined the procedures and sample size requirements for a fully powered RCT |
Study | Subgroups according to physiological testing (if applicable) | Mean symptom duration ± SD (range) | Sex % | Mean age IG in years ± SD (range) | |
---|---|---|---|---|---|
Male | Female | ||||
Anorectal pain syndrome | |||||
Chiarioni et al. 2010 [16] | n.a. | 17.1 ± 4.3 months (“high likely” LAS), 18.6 ± 4.8 (“possible” LAS) | 19% (“high likely” LAS), 33% (“possible” LAS)b | 48% | 41.0 ± 10.0 in “high likely” LAS, 41.4 ± 10.3 in “possible” LASb |
Heah et al. 1997 [17] | n.a. | 32.5 ± 6.7 months | 56.3%b | 43.6%b | 50.5 (39–66) |
Ger et al. 1993 [18] | n.a. | 54 (2–228) months | 42.9%b | 57.1%b | 71 (n.a.)b |
Gilliland et al. 1997a [19] | High resting pressures (manometry): n = 5/14, nonrelaxation or paradoxical PF contraction: n = 7/14, abnormal cinedefecography: n = 14/14 | 36 (3-lifelong) months | 36.0%b | 64.0%b | 68 (12–96)b |
Grimaud et al. 1991 [20] | n.a. | 8 ± 6 (3–72) months | 66.7%b | 33.3%b | 54 ± 3 (24–66)b |
Constipation, dyssynergic defecation | |||||
Chiarioni et al. 2006 [21] | Slow transit constipation was excluded | >12 months | 5.6%b | 94.4b | 33.3 ± 1.5b |
Koutsomanis et al. 1994 [22] | Slow transit: n = 2/20, slow transit + pelvic incoordination: n = 11/20, pelvic incoordination: n = 7/20 | n.a. | 90.0%b | 10.0%b | 34 (18–53)b |
Chiotakakou-Faliakou et al. 1998 [23] | Slow transit: n = 18/100, slow transit + paradoxcial PF contraction: n = 29/100, normal transit: n = 11/100, normal transit + paradoxical PF contraction: n = 15/100 | n.a., median age of onset: 21 (0–70) | 13.0%b | 87.0%b | 40 (10–79)b |
Battaglia et al. 2004 [24] | PF dyssynergia, n = 14/24, slow transit: n = 10/24 | >12 months | 16.7%b | 83.3%b | n.a., (27–54)b |
Wang et al. 2003 [25] | Slow transit: n = 8/50, anorectic outlet obstruction: n = 36/50, both: n = 6/50 | 55.2 (30–360) months | 28.0%b | 72.0%b | 52.6 (16–71)b |
Ba-Bai-Ke-Re et al. 2014 [26] | n.a. | 42 months | n.a. | n.a. | 54 (n.a.) |
Roy et al. 2000 [27] | Rectal prolapse: n = 12/78, rectocele: n = 22/78, slow transit: n = 53/78, paradoxical PF contraction: n = 40/78 | Several years | 0%b | 100%b | n.a. (24–75)b |
Chiarioni et al. 2005 [28] | n.a. | 168 (24–480) months | 05.8%b | 94.2%b | 34.9 ± 10.2 (23–63)b |
Zhu et al. 2011 [29] | n.a. | n.a. | 38.9%b | 61.1%b | 46.4 (21–65)b |
Gilliland et al. 1997b [30] | Fixed or dynamic descent: n = 100/194, rectocele: n = 32/194, intussusception: n = 15/194 | 168 (2–lifelong) months | 30.4%b | 69.6%b | 71 (11–96)b |
Parker et al. 2019 [31] | Chronic constipation + dyssynergic defecation n = 53/130, without: n = 3/130 | n.a. | 20.8%b | 79.2%b | 57.5 ± 16.4b |
Male chronic pelvic pain syndrome, urological chronic pelvic pain syndrome | |||||
Clemens et al. 2000 [32] | n.a. | n.a. | 100%b | 0%b | 38 (18–67)b |
Cornel et al. 2005 [34] | Detrusor instability: n = 5/19, diminished bladder capacity: n = 4/19, dysfunctional voiding of bladder (pseudodyssynergia): n = 6/19, cystometric abnormalities + pseudodyssynergia n = 3/19 | ≥3 months | 100%b | 0%b | 45 (23–70)b |
Yang et al. 2017 [35] | n.a. | 30.4 (6–144) months | 100%b | 0%b | 43.4 (24–68)b |
He et al. 2010 [36] | n.a. | >3 months | 100%b | 0% | n.a. |
Female chronic pelvic pain | |||||
Schmitt et al. 2017 [37] | n.a. | n.a. | 0% | 100% | 52.2 ± 15.4 in n = 29 with pelvic pain |
Glazer et al. 1995 [38] | n.a. | 40.8 (24–72) months | 0% | 100% | 31.5 (21–45) |
McKay et al. 2001 [39] | n.a. | 44.4 (24–60) months | 0% | 100% | 35 (25–48) |
Gentilcore-Saulnier et al. 2010 [40] | n.a. | 48 ± 12 months | 0% | 100% | 22 ± 2 |
Bendana et al. 2009 [41] | n.a. | n.a. | 0% | 100% | 45.0 ± 17, (19–76) |
Philips et al. 1992 [42] | n.a. | 57 (4–240) months | 0%b | 100%b | 25.7 ± 4.7b |
Hart et al. 1981 [43] | n.a. | n.a. | 0% | 100% | 26 ± 6.2 |
Bennink et al. 1982 [44] | n.a. | n.a. | 0%a | 100%a | 19.2 (n.a.)a |
Vagedes et al. 2019 [45] | n.a. | >1 year | 0%a | 100%a | 29.7 ± 8.0a |
Starr et al. 2013 [46] | n.a. | n.a. | 0%b | 100%b | 51 (18–95)b |
Lúcio et al. 2014 [47] | n.a. | 4.1 (0.7–10) months | 0%b | 100%b | 44.5 (36–51)b in intervention group 1 |
Aalaie et al. 2020 [48] | n.a. | n.a. | 0% | 100% | 50.7 ± 6.1 |
Chronic pelvic pain in children | |||||
Hoebeke et al. 2004 [51] | n.a. | 3 months | 9.5% | 90.5% | 8.3 (n.a.) |
Ebiloglu et al. 2016 [52] | Overactive bladder syndrome + dysfunctional voiding: n = 107/136, overactive bladder syndrome only: n = 29/136 | n.a. | 29.0%b | 71.0%b | 8.11 (5–14)b |
Ergin et al. 2016 [53] | n.a. | n.a. | 23.1%b | 76.9%b | 8.84 ± 2.54b |
Li et al. 2006 [54] | n.a. | >3 months | 100%b | 0% | 16.5 ± 1.1 (15–18)b |
Musculoskeletal, low back pain, myofascial pain | |||||
Kent et al. 2015 [55] | n.a. | 13 (4.25–13) months | 48.0b | 52.0%b | 39 ± 12b |
Study | Interventions performed in longitudinal study arm | Time points of follow-up | BFB device details | BFB treatment details: number of sessions, duration per session (min/, frequency) (times/week), duration of whole intervention (weeks, if available) | Setting of BFB intervention (clinical/home-based), home exercise (=HE) encouraged (yes/not addressed) |
---|---|---|---|---|---|
Anorectal pain syndrome | |||||
Chiarioni et al.2010 [16] | IG 1: BFB + psychological counselling (5 sessions BFB + 4 sessions psychological counselling) (n = 52) | Baseline, 1, 3, 6, 12 months | Anal sEMG probe | 5 sessions, 30 min, 1 ×/week | Clinical |
IG 2: EGS (9 sessions, 30–45/min, 3 ×/week) + 4 sessions psychological counselling (n = 52) | Baseline, 1, 3, 6, 12 months | – | – | – | |
IG 3: massage of levator ani muscle (9 sessions, 30–45 min, 3 ×/week) + 4 sessions psychological counselling (n = 53) | Baseline, 1, 3, 6, 12 months | – | – | – | |
Heah et al. 1997 [17] | BFB | Baseline—2 weeks after treatment, mean f/u 12.8 ± 2.6 months | Anorectal manometry (rectal balloon) | 4 sessions, 60 min, 1 ×/week | Clinical (HE: yes) |
Ger et al. 1993 [18] | IG 1: EGS (3 sessions, 30–60 min, 7–10 days) (some had failed BFB, epitural caudal block earlier) | Baseline—mean f/u 15 [2–36] months after treatment | – | – | – |
IG 2: BFB (50% had failed EGS earlier) | Same as IG1 | Anal sEMG probe | ≥6 sessions, 30–60 min, 1 ×/week | Clinical (HE: yes) | |
IG 3: epidural steroid caudal block (some had failed other modalities earlier) | Same as IG1 | – | – | – | |
Gilliland et al. 1997a [19] | BFB including education, stress management and cognitive-behavioral psychotherapy techniques | Baseline—after treatment (time-points varied) | Anal sEMG probe | 2–18 sessions (until improvement/persistent failure/self-discharge), 60 min; frequency n.a. | Clinical (HE: yes) |
Grimaud et al. 1991 [20] | BFB + education | Baseline—after treatment, long term f/u after 16 ± 1 [10–24] months | Anorectal manometry | 5–13 sessions, 30 min, 1 ×/week until pain disappearance (8 ± 1 [5–13] weeks), reeducation sessions over 6 months | Clinical (HE: yes) |
Constipation, dyssynergic defecation | |||||
Chiarioni 2006 [21] | IG1: BFB | Baseline, 6, 12, 24 months after starting treatment | Anal sEMG probe | 5 sessions, 30 min, 1 ×/week | Clinical, laxatives at home |
IG2: laxatives (polyethylene glycol 1–2 packets daily + counselling with physician) | Same as IG1 | – | – | – | |
Koutsomanis et al. 1994 [22] | BFB | Baseline, after treatment, 6 weeks after starting treatment, 6–12 months after 6‑week-f/u | sEMG skin electrodes close to anal verge (external anal sphincter), visual + acoustic feedback | Mean 4 [2–6] sessions (until improvement or persistent failure), 30–45 min, 1 ×/week | Clinical (HE: n.a.) |
Chiotakakou-Faliakou et al. 1998 [23] | BFB + education, balloon defecation training | Baseline, after treatment, long term f/u (mean 23.4 [12–44]) months after treatment | sEMG skin electrodes close to anal verge (external anal sphincter), visual feedback | Mean 4 [1–10] sessions, duration n.a., 1 ×/1–2 weeks | Clinical (HE: yes) |
Battaglia et al. 2004 [24] | BFB + balloon defecation training | Baseline, 3 months, 1 year after treatment | Anal sEMG plug | 8 sessions, duration n.a., 2 ×/week, over 4 weeks | Clinical (HE: yes) |
Wang et al. 2003 [25] | BFB: EMG vs. manometry based BFB | Baseline, after treatment, long term f/u (mean18 [12–28] months after treatment) | EMG based BFB: surface sEMG electrodes (anal sphincter), auditory + visual feedback; manometry based BFB: visual BFB | 5 sessions, 30 min, 1 ×/week | Clinical (HE: yes) |
Ba-Bai-Ke-Re et al. 2014 [26] | IG1: BFB | Baseline, 1, 3, 6 months after treatment | Anorectal manometry | 4–5 sessions, duration n.a., 1/1–2 week | Clinical (HE: yes) |
IG2: laxatives (polyethylene glycol, 17 g 3 ×/day, 2 weeks) | – | – | – | – | |
Roy et al. 2000 [27] | BFB | Baseline, after treatment, long-term f/u (mean 28 [12–44] months after treatment) | sEMG skin electrodes close to anal verge (external anal sphincter), visual feedback | 4–5 sessions, duration n.a. 1/1–2 week | Clinical (HE: n.a.) |
Chiarioni et al. 2005 [28] | BFB + balloon defecation training | Baseline, 1, 6, 12, 24 months after treatment | Anal sEMG plug, visual feedback | 5 sessions, 30–45 min, 1 ×/week | Cinical (HE: n.a.) |
Zhu et al. 2011 [29] | BFB | Baseline—after treatment (n.a.) | Water-perfused intra-anal instrument, visual + verbal feedback | 6–10 sessions, 30–60 min, frequency n.a., over 4–8 weeks | Clinical (HE: yes) |
Gilliland et al. 1997b [30] | BFB (+education, stress management, lifestyle modification) | Baseline—after treatment (n.a.) | Anal sEMG probe | 2–>30 sessions (until symptom resolution/control over PF muscles in EMG/self-discharge: mean self-discharged: 5, finished: 11), 60 min, further data n.a | Clinical (HE: yes) |
Parker et al. 2019 [31] | BFB (+education, exercise instructions, diet) | Baseline—after treatment (n.a.) | Anorectal manometry, visual feedback | Mean 2.9 [2–3] sessions, further data n.a. | Clinical (HE: yes) |
Male chronic pelvic pain syndrome, Urological Chronic Pelvic Pain Syndrome | |||||
Clemens et al. 2000 [32] | BFB (PF reeducation + bladder training) | Baseline—mean 5.8 [1.6–14.8] months after treatment | sEMG electrodes | ≤6 sessions, 60 min, 1 ×/2 week | Clinical (HE: yes) |
Cornel et al. 2005 [34] | BFB | Baseline—after treatment (n.a.) | Anal sEMG probe | 6–8 sessions, 1 ×/week, later 1 ×/2–4 weeks, duration n.a. | Clinical (HE: n.a.) |
Yang et al. 2017 [35] | IG 1: EGS + BFB | Baseline—12 weeks after treatment | Anal sEMG probe | 8 sessions, 45 min (15 min BFB, 30 min EGS), 1–2 ×/week, over 6 weeks | Clinical (HE: n.a.) |
IG 2: electomagnetic stimulation (18 sessions, 30 min, 3 ×/week, 6 weeks) | Baseline—12 weeks after treatment | – | – | – | |
He et al. 2010 [36] | BFB | Baseline—10 weeks after treatment | Anal sEMG probe | No. sessions n.a., 30 min, 2–3 ×/week, over several weeks | Clinical (HE: n.a.) |
Female chronic pelvic pain | |||||
Schmitt et al. 2017 [37] | BFB + vaginal EGS + behavioral modification + pharmacologic therapies for urinary and defecatory management | Baseline, after 1st, 3rd, final treatment session | sEMG skin electrodes (abdominals), vaginal/rectal sEMG probe | 4–7 sessions (until ≥ 80% improvement), BFB + 30 min vaginal EGS, 1 ×/2 week | Clinical (HE: yes) |
Glazer et al. 1995 [38] | BFB | Baseline, f/u at 6 clinical evaluation appointments + 6 months after 6th reevaluation | sEMG portable vaginal probe, visual feedback | 20 min, 2 ×/day, 7 ×/week, after 6 evaluations: exercises continued without BFB ≥ 3 months | Home-based, 6 × clinical f/u |
McKay et al. 2001 [39] | BFB | Baseline, f/u every 4 weeks | sEMG portable vaginal probe, visual feedback | No. sessions n.a., duration n.a., 60 repetitions, 2 ×/day, 7 ×/week, up to 11 months | Home-based, 1 ×/4 weeks clinical f/u |
Gentilcore-Saulnier et al. 2010 [40] | BFB + education, manual therapy, EGS, dilator insertion | Baseline—after treatment (n.a.) | sEMG vaginal probe (deep PF), sEMG electrodes (superficial PF) | 8 sessions, 60–75 min overall (10–15 min BFB), frequency n.a, over 12 ± 3 weeks | Clinical (HE: yes) |
Bendana et al. 2009 [41] | BFB + education, vaginal EGS | Baseline, after treatment, 3 months after treatment | sEMG vaginal probe | 6 sessions, 60 min (10 min BFB, 20 min EGS), 1 ×/week | Clinical (HE: n.a.) |
Philips et al. 1992 [42] | IG1: BFB (±retention control/pain management techniques) | Baseline, after treatment, 2 months after treatment | Perivaginal sEMG electrodes, visual feedback | Mean 8 [5–12] sessions (until aim reached), further data n.a. | Clinical (HE: yes) |
IG2: progressive muscle relaxation (±retention control/pain management), session number same as yoked partner in BFB group | Same as IG1 | – | – | – | |
Comparison group: no intervention (cross-over after 2 months) | Same as IG1 | – | – | – | |
Hart et al. 1981 [43] | IG 1: EMG general relaxation BFB | Baseline, after treatment (8 weeks), 8 weeks after treatment | sEMG electrodes frontalis muscle, aural feedback | Mean: 12.9 [9–15] sessions, 30 min, 2 ×/week, over 2 menstrual cycles | Clinical (HE: yes) |
IG2: temperature general relaxation BFB | Same as IG1 | Skin temperature, visual + aural feedback | Same as IG1 | Same as IG1 | |
Bennink et al. 1982 [44] | IG1: BFB + general relaxation | Baseline (interview), after first menstrual cycle (before treatment) and ~1 week after 3rd or 4th cycle (post treatment) | sEMG electrodes (lower abdomen), aural feedback | 5 sessions, 30 min, 3 sessions before, 2 sessions on first 2 days of period | Clinical (HE: yes) |
IG2: same general and PF relaxation training without BFB | Same as IG1 | – | – | – | |
CG: no intervention | Same as IG1 | – | – | – | |
Vagedes et al. 2019 [45] | IG1: BFB—slow breathing technique (general relaxation) | Baseline—after treatment (n.a.) | Heart rate variability Qiu (Biosign) device, visual feedback | 15 min/day, 7 ×/week, over 12 weeks | Home-based, clinical f/u after 1, 3, then every 4 weeks |
IG2: rhythmical massage (anthroposophic medicine) 30–45 min, 1 ×/week, 3 months | Same as IG1 | – | – | – | |
CG: standard care (analgesics, physical exercise, warmth) | Same as IG1 | – | – | – | |
Starr et al. 2013 [46] | Complex PF rehabilitation: instruction, behavioral management, EGS, BFB | 2nd BFB treatment—after treatment | sEMG electrodes (abdominals), vaginal sEMG probe, anorectal manometry | 5–8 sessions (8 if improvement < 80% after 5 sessions), 1 ×/2 weeks | Clinical (HE: yes) |
Lúcio et al. 2014 [47] | IG1: BFB + PF muscle training + placebo EGS | Baseline—after treatment (12 weeks) | sEMG vaginal probe | 24 sessions, 30 min, 2 ×/week, 12 weeks | Clinical (HE: yes) |
IG2: BFB + PF muscle training + vaginal EGS (30 min, 2 ×/week, 12 weeks) | Same as IG1 | Same as IG1 | Same as IG1 | Same as IG1 | |
IG3: BFB + PF muscle training + transcutaneous tibial nerve stimulation (30 min, 2 ×/week, 12 weeks) | Same as IG1 | Same as IG1 | Same as IG1 | Same as IG1 | |
Aalaie et al. 2020 [48] | IG1: BFB, 100 min, 2 ×/week, 6 weeks + Kegel exercises at home | Baseline—2, 3 months after treatment | sEMG vaginal probe | 12 sessions, 100 min, 2 ×/week, over 6 weeks | Clinical (HE: yes) |
IG2: vaginal EGS (50 min of stimulation, 2 ×/week, 6 weeks) + Kegel exercises at home | Same as IG1 | – | – | – | |
Chronic pelvic pain in children | |||||
Hoebeke et al. 2004 [51] | BFB ± anticholinergics (n = 13/21 with detrusor hyperactivity) | Baseline, after treatment (12 weeks) | Anal plug sEMG, visual BFB | 12 sessions, duration n.a., 1 ×/week | Clinical (HE: n.a.) |
Ebiloglu et al. 2016 [52] | BFB | Baseline, f/u at 3rd and 6th month (total treatment time: 6 months) | Uroflowmeter + sEMG perineal electrodes (external sphincter), visual feedback | 4 sessions, 10 min, 1 ×/week (1st month), then continued without BFB, f/u BFB at 3rd, 6th month | Clinical (HE: yes) |
Ergin et al. 2016 [53] | BFB | Baseline, after treatment (6 months) | Uroflowmetry including sEMG | ≥6 sessions, over 6 months, further data n.a. | Clinical (HE: n.a.) |
Li et al. 2006 [54] | BFB | Baseline, f/u after ~12 weeks | Urodynamic system: anal sEMG probe, abdominal pressure (intra-anal balloon catheter) | No. sessions n.a., 20–30 min, 2–3 ×/week, over several weeks | Clinical (HE: n.a.) |
CG: healthy controls, no intervention | – | – | – | – | |
Musculoskeletal, low back pain, myofascial pain | |||||
Kent et al. 2015 [55] | IG-BFB: BFB based movement modification + education, guidelines-based medical or physiotherapy care | 6 × during 10-weeks of treatment (baseline, week 1, 3, 6, 8, 10), f/u at week 12, 26, 52 | Motion-sensor movement biofeedback (ViMove device), sEMG sensors, aural + vibrational feedback | 6 (subacute pain)–8 (chronic pain) sessions, over 10 weeks, frequency n.a. | Clinical + home-based |
IG-placebo: placebo + education, guidelines-based medical or physiotherapy care | Same as IG-BFB | – | – | – |
Study | n (total) (group 1, 2) | Group 1 (n1) | Group 2 (n2) | Outcome measure | Mean difference: Group 2 minus Group 1 [CI] | Effect size [strength] | P-value (for difference in means) |
---|---|---|---|---|---|---|---|
Anorectal pain syndrome | |||||||
Chiarioni et al. 2010 [16] | 104 | IG1 (BFB) in pat. w LAS (52) | IG2 (EGS) in pat. w LAS (52) | SR: % pat. w adequate pain relief after 1 month | −26.9 | n.a. | p < 0.01f |
104 | IG1 (BFB) in pat. w LAS (52) | IG2 (EGS) in pat. w LAS (52) | SR: % pat. w adequate pain relief after 3 months | −18.9 | n.a. | p < 0.01f | |
104 | IG1 (BFB) in pat. w LAS (52) | IG2 (EGS) in pat. w LAS (52) | SR: % pat. w adequate pain relief after 6 months | −31.2 | n.a. | p < 0.01f | |
104 | IG1 (BFB) in pat. w LAS (52) | IG2 (EGS) in pat. w LAS (52) | SR: % pat. w adequate pain relief after 12 months | −31.2 | n.a. | p < 0.01f | |
105 | IG1 (BFB) in pat. w LAS (52) | IG3 (massage) in patients with LAS (53) | SR: % pat. w adequate pain relief after 1 month | −31.3 | n.a. | p < 0.01f | |
105 | IG1 (BFB) in pat. w LAS (52) | IG3 (massage) in patients with LAS (53) | SR: % pat. w adequate pain ↓ after 3, 6, 12 months | −36.9 | n.a. | p < 0.01f | |
104 | BFB in pat. w “high likely” LAS (n.a.) | EGS in pat. w “high likely” LAS (n.a.) | SR: % pat. w adequate pain relief after 1, 3, 6, 12 months | In favour of BFB group | n.a. | p < 0.025f | |
105 | BFB in pat. w “high likely” LAS (n.a.) | Massage in pat. w “high likely” LAS (n.a.) | n.a. | p < 0.025f | |||
104 | BFB in pat. w “possible” LAS (n.a.) | EGS in pat. w “possible” LAS (n.a.) | SR: % pat. w adequate pain relief after 1, 3, 6, 12 months | – | n.a. | p > 0.025f | |
105 | BFB in pat. w “possible” LAS (n.a.) | Massage in pat. w “possible” LAS (n.a.) | – | n.a. | p > 0.025f | ||
104 | BFB in pat. w “high likely” LAS (n.a.) | EGS in pat. w “high likely” LAS (n.a.) | Subjective change in pain to baseline, ordinal scale [−2 to +3: −2 “a lot worse” to +3 “a lot better/cured”] after 1, 3, 6 months | In favour of BFB group | n.a. | p < 0.025d | |
105 | BFB in pat. w “high likely” LAS (n.a.) | Massage in pat. w “high likely” LAS (n.a.) | n.a. | p < 0.025d | |||
104 | BFB in pat. w “possible” LAS (n.a.) | EGS in pat. w “possible” LAS (n.a.) | – | n.a. | p > 0.025d | ||
105 | BFB in pat. w “possible” LAS (n.a.) | Massage in pat. w “possible” LAS (n.a.) | – | n.a. | p > 0.025d | ||
104 | BFB in pat. w “high likely” LAS (n.a.) | EGS in pat. w “high likely” LAS (n.a.) | Number of days/months with rectal pain as stated in symptom log (0–30 days) after 1, 3, 6 months | In favour of BFB group | n.a. | p < 0.025d | |
105 | BFB in pat. w “high likely” LAS (n.a.) | Massage in pat. w “high likely” LAS (n.a.) | n.a. | p < 0.025d | |||
104 | BFB in pat. w “possible” LAS (n.a.) | EGS in pat. w “possible” LAS (n.a.) | – | n.a. | p > 0.025d | ||
105 | BFB in pat. w “possible” LAS (n.a.) | Massage in pat. w “possible” LAS (n.a.) | – | n.a. | p > 0.025d | ||
104 | BFB in pat. w “high likely” LAS (n.a.) | EGS in pat. w “high likely” LAS (n.a.) | Pain: VAS (0–10 cm), average value of worst pain/wk, after 1, 3, 6 months | In favour of BFB group | n.a. | p < 0.025d | |
105 | BFB in pat. w “high likely” LAS (n.a.) | Massage in pat. w “high likely” LAS (n.a.) | n.a. | p < 0.025d | |||
104 | BFB in pat. w “possible” LAS (n.a.) | EGS in pat. w “possible” LAS (n.a.) | – | n.a. | p > 0.025d | ||
105 | BFB in pat. w “possible” LAS (n.a.) | Massage in pat. w “possible” LAS (n.a.) | – | n.a. | p > 0.025d | ||
Heah et al. 1997 [17] | 16 | Study group pre-BFB (16) | Study group post-BFB (16) | Pain VAS (0–10) | −6 | n.a. | p < 0.02 |
16 | Study group pre-BFB (16) | Study group post-BFB (16) | SR: % pat. needing analgesics | −87.5 | n.a. | p < 0.03 | |
Ger et al. 1993 [18] | 14 | n/a | IG2 (BFB group) post-BFB (14) | SR: % pat. w complete pain relief | 14.3 | n.a. | n.a. |
14 | n/a | IG2 (BFB group) post-BFB (14) | SR: % pat. w improved pain frequency/intensity | 28.6 | n.a. | n.a. | |
14 | n/a | IG2 (BFB group) post-BFB (14) | SR: % pat. w no improvement | 57.1 | n.a. | n.a. | |
Gilliland et al. 1997a [19] | 75 | BFB in pat. w rectal pain only (47) | BFB in pat. with rectal pain and constipation (28) | SR: % patients reporting symptom improvement | −4.02 | n.a. | p = 0.81 |
46 | BFB subgroup of Group 1: pat. who finished trial (7) | BFB subgroup of Group 1: self-discharged early (39) | −57.5 | n.a. | p < 0.01 | ||
28 | BFB subgroup of Group 2: pat. who finished trial (n.a.) | BFB subgroup of Group 2: self-discharged early (n.a.) | −46.7 | n.a. | p < 0.05 | ||
Constipation, dyssynergic defecation | |||||||
Chiarioni et al. 2006 [21] | 54 | IG1 (BFB) pre-treatment (54) | IG1 (BFB) 6 months after starting treatment (54) | Frequency of abdominal pain/wk (symptom diary) | −0.69 [−0.74;−0.64] | −5.86 [H] | p < 0.01c |
54 | IG1 (BFB) pre-treatment (54) | IG1 (BFB) 12 months after starting treatment (54) | −0.68 [−0.73; −0.63] | −5.78 [H] | p < 0.01c | ||
109 | IG1 (BFB) 6 months after starting treatment (54) | IG2 (laxatives) 6 months after starting treatment (55) | 0.63 [0.57;0.69] | 4.85 [H] | p < 0.01c | ||
109 | IG1 (BFB) 6 months after starting treatment (54) | IG2 (laxatives) 12 months after starting treatment (55) | 0.58 [0.52;0.64] | 4.26 [H] | p < 0.01c | ||
109 | IG1 (BFB) 6 + 12 months after starting treatment (54) | IG2 (laxatives) 6 + 12 months after starting treatment (55) | SR: % patients reporting symptom improvement (4 out of a scale 0–4) | −57.8 | n.a. | n.a. | |
54 | n/a | IG1 (BFB) 6 + 12 months after starting treatment (54) | 79.6 | n.a. | n.a. | ||
54 | n/a | IG1 (BFB) 24 months after starting treatment (54) | 81.5 | n.a. | n.a. | ||
Koutsomanis et al. 1994 [22] | 20 | Study group pre-BFB (20) | Study group immediately post-BFB (20) | SR: % patients reporting abdominal pain ≥ 1/week | −20 | n.a. | ≥0.05b |
18 | Study group pre-BFB (20) | Study group 6 weeks after starting BFB (18) | −13.3 | n.a. | ≥0.05b | ||
20 | Study group pre-BFB (20) | Study group 6–12 months after 6‑wk-f/u (20) | −10 | n.a. | ≥0.05b | ||
20 | Study group pre-BFB (20) | Study group immediately post-BFB (20) | Weekly total pain score (daily pain score: 0 = none, 3 = severe) | −5.5 | n.a. | ≥0.05b | |
18 | Study group pre-BFB (20) | Study group 6 weeks after starting BFB (18) | −8 | n.a. | p < 0.01b | ||
20 | Study group pre-BFB (20) | Study group 6–12 months after 6‑wk-f/u (20) | −9 | n.a. | p < 0.01b | ||
20 | Study group pre-BFB (20) | Study group immediately post-BFB (20) | Weekly overall symptom score (daily score: 0 = better, 1 = same, 2 = worse) | −4 | n.a. | p < 0.01b | |
18 | Study group pre-BFB (20) | Study group 6 weeks after starting BFB (18) | −4 | n.a. | p < 0.01b | ||
20 | Study group pre-BFB (20) | Study group 6–12 months after 6‑wk-f/u (20) | −6 | n.a. | p < 0.01b | ||
Chiotakakou-Faliakou et al. 1998 [23] | 100 | Study group pre-BFB (100) | Study group post-BFB (100) | SR: % patients with abdominal pain | −16 | n.a. | p = 0.003f |
100 | Study group pre-BFB (100) | Study group long-term (mean 23.4 months) post-BFB (100) | −20 | n.a. | p = 0.0004f | ||
100 | n/a | Study group post-BFB (100) | SR: % patients stating BFB improved bowel symptoms (a little‑a lot) | 66 | n.a. | n.a. | |
100 | n/a | Study group long-term (mean 23.4 months) post-BFB (100) | 55 | n.a. | n.a. | ||
100 | n/a | Study group post-BFB (100) in pat. w constipation | SR: % patients reporting sonstipation symptom improvement (a little‑a lot) | 50 | n.a. | n.a. | |
100 | n/a | Study group long-term (23.4 months) post-BFB (100) in pat. w constipation | 57 | n.a. | n.a. | ||
Battaglia et al. 2004 [24] | 14 | Subgroup with PF dyssynergia pre-BFB (14) | This subgroup 3 + 12 months after BFB (14) | SR: % patients with abdominal pain | −21.4 | n.a. | n.a. |
10 | Subgroup with slow transit constipation pre-BFB (10) | This subgroup 3 months post-BFB (10) | −80 | n.a. | n.a. | ||
10 | Subgroup with slow transit constipation pre-BFB (10) | This subgroup 12 months post-BFB (10) | −20 | n.a. | n.a. | ||
Wang et al. 2003 [25] | 50 | Study group pre-BFB (50) | Study group post-BFB (50) | SR: % patients with perianal pain at defacation | −28 | n.a. | ≥0.05a |
50 | Study group pre-BFB (50) | Study group 1‑year post-BFB (50) | −38 | n.a. | ≥0.05a | ||
50 | n/a | Study group post-BFB (50) | SR: % patients reporting overall symptom improvement | 62 | n.a. | n.a. | |
8 | n/a | Pat. w slow transit constipation post-BFB (8) | 37.5 | n.a. | n.a. | ||
36 | n/a | Pat. w PF dysfunction post-BFB (36) | 72.2 | n.a. | n.a. | ||
6 | n/a | Pat. w combined PF dysf. +slow transit post-BFB (6) | 33.3 | n.a. | n.a. | ||
Ba-Bai-Ke-Re et al. 2014 [26] | 88 | IG1 (BFB) 1 month post-treatment (44) | IG2 (laxatives) 1 month post-treatment (44) | SR; % of patients with peri-anal pain at defecation | 36.4 | n.a. | 0.0006a |
88 | IG1 (BFB) 3 months post-treatment (44) | IG2 (laxatives) 3 months post-treatment (44) | 20.5 | n.a. | 0.0534a | ||
88 | IG1 (BFB) 6 months post-treatment (44) | IG2 (laxatives) 6 months post-treatment (44) | 20.5 | n.a. | 0.0375a | ||
88 | IG1 (BFB) 1 month post-treatment (44) | IG2 (laxatives) 1 month post-treatment (44) | Symptom score: Wexner constipation summary score (0–30 = worst) [62] | −6.00 [−7.41; −4.59] | −1.45 [VL] | p < 0.001a | |
88 | IG1 (BFB) 3 months post-treatment (44) | IG2 (laxatives) 3 months post-treatment (44) | −5.00 [−6.21;−3.78] | −1.40 [VL] | p < 0.001a | ||
88 | IG1 (BFB) 6 months post-treatment (44) | IG2 (laxatives) 6 months post-treatment (44) | −6.00 [−7.11; −4.89] | −1.84 [VL] | p < 0.001a | ||
Roy et al. 2000 [27] | 26 | Pre-BFB in pat. w constipation, attributed to hysterectomy by patient (26) | Post-BFB in patients with constipation, attributed to hysterectomy by patient (26) | SR: % of patients with abdominal pain | −23.1 | n.a. | n.a. |
26 | Pre-BFB in pat. w constipation, attributed to hysterectomy (26) | Long-term (28 months) post-BFB in patients with constipation, attributed to hysterectomy (26) | −11.5 | n.a. | n.a. | ||
27 | Pre-BFB in pat. w constipation, not attributed to hysterectomy (27) | Post-BFB in pat. w constipation, not attributed to hysterectomy (27) | −29.6 | n.a. | n.a. | ||
27 | Pre-BFB in pat. w constipation, not attributed to hysterectomy (27) | Long-term (28 months) post-BFB in pat. w constipation, not attributed to hysterectomy (27) | −29.6 | n.a. | n.a. | ||
25 | Pre-BFB in pat. w constipation, no history of hysterectomy (25) | Post-BFB in pat. w constipation, no history of hysterectomy (25) | −28.0 | n.a. | n.a. | ||
25 | Pre-BFB in pat. w constipation, no history of hysterectomy (25) | Long-term (28 months) post-BFB in pat. w constipation, no history of hysterectomy (25) | −36.0 | n.a. | n.a. | ||
78 | Pre-BFB in all pat. w constipation (78) | Post-BFB in all pat. w constipation (78) | −27.0 | n.a. | n.a. | ||
78 | Pre-BFB in all pat. w constipation (78) | Long-term (28 months) post-BFB in all pat. w constipation (78) | −25.6 | n.a. | n.a. | ||
78 | n/a | 28 months post-BFB in all pat. w constipation (78) | SR: % patients reporting constipation symptom improvement | 61.5 | n.a. | n.a. | |
Chiarioni et al. 2005 [28] | 41 | Subgroup with PF dysfunction after 1, 6, 12, 24 months after BFB (52, 50, 49, 45) | Subgroup with slow transit only, after 1, 6, 12, 24 months after BFB (52, 50, 49, 45) | Pain frequency (in favour of subgroup PF dyssynergia) | n.a. | n.a. | p < 0.05a |
Zhu et al. 2011 [29] | 36 | Study group pre-BFB (36) | Study group post-BFB (36) | SF-36 subscale pain (0–100: best) | 10.3 [−1.31;21.91] | 0.48 [S] | p = 0.001a |
36 | Study group pre-BFB (36) | Study group post-BFB (36) | Symptom score (0–15 : 0 = none, 3 = severe for 5 symptoms) | −5.77 [−7.29;−4.25] | −2.04 [H] | p < 0.001a | |
Gilliland et al. 1997b [30] | 178 | n/a | Study group post-BFB (178) | SR: % patients with ≥ 3 bowel movements/wk without aid (“complete success”) | 35.0 | n.a. | n.a. |
178 | n/a | Study group post-BFB (178) | SR: % patients with < 3 bowel movements/wk with reduced aid (“partial success”) | 13.5 | n.a. | n.a. | |
178 | n/a | Study group post-BFB (178) | SR: % patients with no improvement (“failed”) | 51.1 | n.a. | n.a. | |
60 | n/a | Study group post-BFB, pat. attended 2–4 sessions (60) | SR: % patients with ≥ 3 bowel movements/wk without aid (“complete success”) | 18.0 | n.a. | n.a. | |
118 | n/a | Study group post-BFB, pat. attended ≥ 5 sessions (118) | 44.0 | n.a. | n.a. | ||
178 | n/a | Study group post-BFB, pat. attended 2–4 sessions (60) | −26.0 | n.a. | p < 0.001 | ||
52 | n/a | Study group post-BFB, pat. completed BFB (52) | 63.0 | n.a. | n.a. | ||
126 | – | Study group post-BFB, pat. not completed BFB (126) | (25.0) | n.a. | n.a. | ||
178 | Study group post-BFB, pat. completed BFB (52) | Study group post-BFB, pat. not completed BFB (126) | −38.0 | n.a. | n.a. | ||
Parker et al. 2019 [31] | 130 | n/a | Whole study group post-BFB (130) | SR: % patients reporting symptom improvement (±improvement in anorectal manometry profile) | (55.4) | n.a. | n.a. |
53 | n/a | Subgroup with constipation + dys. defecation post-BFB (53) | (45.3) | n.a. | n.a. | ||
3 | n/a | Subgroup with rectal pain post-BFB (3) | (0.0) | n.a. | n.a. | ||
Male chronic pelvic pain syndrome, Urological Chronic Pelvic Pain Syndrome | |||||||
Clemens et al. 2000 [32] | 16 | Study group pre-BFB (19) | Study group 6 months post-BFB (16) | Pain VAS (0–9) | −4 | n.a. | p = 0.001b |
16 | Study group pre-BFB (19) | Study group 6 months post-BFB (16) | Symptom score: AUA [59] | −7.5 | n.a. | p = 0.001b | |
Cornel et al. 2005 [34] | 31 | Pstudy group re-BFB (33) | Study group post-BFB (31) | Symptom score: NIH-CPSI subdomain pain (0–21) | −5.3 | n.a. | p = 0.001b |
31 | Study group pre-BFB (33) | Study group post-BFB (31) | Symptom score: NIH-CPSI | −12.2 | n.a. | p = 0.001b | |
Yang et al. 2017 [35] | 22 | IG1 (BFB + EGS) pretreatment (24) | IG1 (BFB + EGS) 12 weeks post-treatment (22) | Pain VAS (0–10) | −3.5 [−4.91;−2.09] | −1.74 [VL] | p = 0.001b |
45 | IG1 (BFB + EGS) 12 weeks post-treatment (22) | IG2 (PEMF) 12 weeks post-treatment (23) | 0.6 [−1.44;0.24] | −0.34 [S] | p = 0.084a | ||
22 | IG1 (BFB + EGS) pretreatment (24) | IG1 (BFB + EGS) 12 weeks post-treatment (22) | NIH-CPSI subdomain pain (0–21) | −8.3 [−10.91;−5.70] | −2.23 [H] | p < 0.001a | |
45 | IG1 (BFB + EGS) 12 weeks post-treatment (22) | IG2 (PEMF) 12 weeks post-treatment (23) | 0.1 [−1.98;1.78] | −0.03 [VS] | p = 0.035a | ||
22 | IG1 (BFB + EGS) pretreatment (24) | IG1 (BFB + EGS) 12 weeks post-treatment (22) | Symptom score: NIH-CPSI total score (0–43) | −14.3 [−19.82;−8.78] | −1.81 [VL] | p < 0.001a | |
45 | IG1 (BFB + EGS) 12 weeks post-treatment (22) | IG2 (PEMF) 12 weeks post-treatment (23) | 0.5 [−3.98;2.98] | −0.07 [VS] | p = 0.009a | ||
22 | IG1 (BFB + EGS) pretreatment (24) | IG1 (BFB + EGS) 12 weeks post-treatment (22) | Symptom score: IPPS | −4.6 [−8.64;−0.56] | −0.80 [M] | p = 0.004a | |
45 | IG1 (BFB + EGS) 12 weeks post-treatment (22) | IG2 (PEMF) 12 weeks post-treatment (23) | 1.80 [−3.57;−0.03] | −0.49 [S] | p = 0.663a | ||
He et al. 2010 [36] | 21 | Study group pre-BFB (21) | Study group 10 weeks post-BFB (21) | NIH-CPSI subdomain pain (0–21) | −1.80 [−3.13;−0.47] | −0.97 [L] | p < 0.05b |
21 | Study group pre-BFB (21) | Study group 10 weeks post-BFB (21) | Symptom score: NIH-CPSI total score (0–43) | −13.3 [−16.7;−9.92] | −2.83 [H] | p < 0.05b | |
Female chronic pelvic pain | |||||||
Schmitt 2017 et al. [37] | 26 | Subgroup w pelvic pain/dyspareunia pre-treatment (29) | Subgroup w pelvic pain/dyspareunia after 3rd treatment (26) | Pelvic pain VAS (0–10) | −1 | n.a. | p = 0.99b |
27 | Subgroup w pelvic pain/dyspareunia pre-treatment (29) | Subgroup w pelvic pain/dyspareunia after final treatment (27) | −3 | n.a. | p = 0.27b | ||
26 | Subgroup w pelvic pain/dyspareunia after 3rd treatment (26) | Subgroup w pelvic pain/dyspareunia after final treatment (27) | −2 | n.a. | p = 0.02b | ||
27 | Subgroup w pelvic pain/dyspareunia after 3rd treatment (28) | Subgroup w pelvic pain/dyspareunia after final treatment (27) | Rating treatment success pelvic pain (0: none–10: very successful) | 2 | n.a. | p = 0.51b | |
14 | Subgroup w pelvic pain/dyspareunia after 3rd treatment (14) | Subgroup w pelvic pain/dyspareunia after final treatment (16) | Rating treatment success dyspareunia (0: none–10: very successful) | 3 | n.a. | p = 0.20b | |
79 | Subgroup w urinary symptoms after 3rd treatment (80) | Subgroup w urinary symptoms after final treatment (79) | Rating treatment success urinary symptoms (0: none–10: very successful) | 2 | n.a. | p < 0.001b | |
15 | Subgroup w defecatory symptoms after 3rd treatment (16) | Subgroup w defecatory symptoms after final treatment (15) | Rating treatment success defecatory symptoms (0: none–10: very successful) | 1 | n.a. | p = 0.003b | |
Glazer et al. 1995 [38] | 33 | Study group pre-BFB (33) | Study group after 6th clinical reevaluation with BFB (33) | Pelvic pain VAS (0–10) | −5.7 | n.a. | p < 0.001b |
33 | Study group pre-BFB (33) | Study group 6 months after 6th clinical reevaluation (33) | −6 | n.a. | p < 0.001b | ||
33 | Study group pre-BFB (33) | Study group after 6th clinical reevaluation + 6 months later (33) | SR: % of patients reporting intercrouse ≥ 1/month | 66.67 | n.a. | p < 0.001b | |
McKay et al. 2001 [39] | 11 | Study group 1 month post-BFB (19) | Study group 6 months post BFB (11) | Pelvic pain VAS (0–10) | −6.8 | n.a. | n.a. |
11 | Study group 1 month post-BFB (19) | Study group 6 months post BFB (11) | SR: % patients reporting intercourse | 88.9 | n.a. | n.a. | |
Gentilcore-Saulnier et al. 2010 [40] | 11 | IG pre-BFB in pat. with provoked vestibulodynia (11) | IG post-BFB in pat. w provoked vestibulodynia (11) | Pain NRS (0–10) during digital intravaginal assessment of superficial + deep PF | −2.00 [−3.33;−0.67] | −1.56 [VL] | p = 0.007a |
22 | IG pre-BFB in pat. w provoked vestibulodynia (11) | Healthy CG without intervention (11) | −2.13 [−1.27;−2.99] | −1.73 [VL] | p = 0.002a | ||
22 | IG post-BFB in pat. w provoked vestibulodynia (11) | Healthy CG without intervention (11) | −0.13 [−0.26;0.52] | 0.23 [S] | p = 0.58a | ||
11 | IG pre-BFB in pat. w provoked vestibulodynia (11) | IG post-BFB in pat. w provoked vestibulodynia (11) | “unpleasantness” NRS (0–10) during manual assessment | −1.63 [−3.03;−023] | −1.21 [VL] | p = 0.0009a | |
22 | IG pre-BFB in pat. w provoked vestibulodynia (11) | Healthy CG without intervention (11) | −0.54 [−0.50;1.58] | 0.36 [S] | p = 0.40a | ||
22 | IG post-BFB in pat. w provoked vestibulodynia (11) | Healthy CG without intervention (11) | −1.09 [−2.01;−0.17] | −0.83 [L] | p = 0.07a | ||
11 | IG pre-BFB in pat. w provoked vestibulodynia (11) | IG post-BFB in pat. w provoked vestibulodynia (11) | Painful pressure stimulus intensity levels (pressure to induce pain NRS 6/10, g/cm2) | 92.00 [−162.25;346.25] | 0.37 [S] | p = 0.07a | |
22 | IG pre-BFB in pat. w provoked vestibulodynia (11) | Healthy CG without intervention (11) | 201.00 [−366.64;−35.36] | −0.85 [L] | p = 0.001a | ||
22 | IG post-BFB in pat. w provoked vestibulodynia (11) | Healthy CG without intervention (11) | 109.00 [−246.63;28.63] | −0.56 [M] | p = 0.03a | ||
Bendana et al. 2009 [41] | 21 | Study group pre-BFB (52) | Study group 3 months post-BFB (21) | AUA symptom score—total score (0–35) | −7.97 [−12.25;−4.62] | −1.10 [L] | p < 0.001a |
21 | Study group pre-BFB (52) | Study group 3 months post-BFB (21) | American Urological Association bother score (0–6) | −1.53 [−2.33; −0.87] | −1.13 [L] | p < 0.001a | |
13 | Study group pre-BFB (52) | Study group 3 months post-BFB (13) | VAS for symptom severity (1 = lowest 10 = most severe) | −2.44 [n.a.] | n.a. | p < 0.001a | |
Philips et al. 1992 [42] | 10 | IG1 (BFB group) pre-BFB (10) | IG1 (BFB group) post-BFB (10) | Pain score: self-monitored | −1.30 [−29.40;26.80] | −0.05 [VS] | n.a. |
10 | IG1 (BFB group) pre-BFB (10) | IG1 (BFB group) 2 months post-BFB (10) | −11.40 [−26.55;3.75] | −0.82 [L] | n.a. | ||
Hart et al. 1981 [43] | 5 | IG1: EMG BFB (5) baseline | IG1: EMG BFB (5) posttreatment | Symptom score: SSS total score: total of 15 symptoms (1 best −5 worst) | −7.00 [−11.85; −2.15] | −2.51 [H] | n.a. |
5 | IG1: EMG BFB (5) baseline | IG1: EMG BFB (5) 8 weeks posttreatment | −9.30 [−12.61; −6.00] | −4.89 [H] | n.a. | ||
6 | IG2: BFB skin temperature baseline (6) | IG2: BFB skin temperature posttreatment (6) | −2.00 [−8.86;4.86] | −0.44 [S] | n.a. | ||
6 | IG2: BFB skin temperature baseline (6) | IG2: BFB skin temperature 8 weeks posttreatment (6) | −8.10 [−14.25; −1.95] | −2.00 [H] | n.a. | ||
Bennink et al. 1982 [44] | 5 | IG1 (relaxation + EMG BFB) pretreatment (5) | IG1 (relaxation + EMG BFB) posttreatment (5) | Symptom score: SSS total of 15 symptoms (1 best −5 worst) | −3.6 [−14.27;7.07] | −0.59 [M] | n.a. |
5 | IG1 (relaxation + EMG BFB) pretreatment (5) | IG1 (relaxation + EMG BFB) posttreatment (5) | SSS of subdomain cramps, backache, abdominal pain (1–5 = very severely) | −1.6 [−4.63;1.43] | −0.92 [L] | n.a. | |
5 | IG1 (relaxation + EMG BFB) pretreatment (5) | IG1 (relaxation + EMG BFB) posttreatment (5) | SSS of subdomain cramps only (1–5 = very severely) | −0.6 [−1.47;0.27] | −1.19 [L] | n.a. | |
Vagedes et al. 2019 [45] | 20 | IG1 (BFB group) pre-BFB (20) | IG1 (BFB group) post-BFB (20) | Mean NRS (0–10) pain during menstruation | −0.3 [−1.2/0.6]g | −0.2 [VS]g | n.a. |
37 | IG1 (BFB group) postBFB (20) | No treatment CG (17) | 0.9 [−2.10/0.30]g | −0.51 [M]g | p = 0.211 | ||
43 | IG1 (BFB group) postBFB (20) | IG2 (rhythmical massage) post treatment (23) | −0.6 [−1.82/0.40]g | −0.34 [S]g | p = 0.361 | ||
20 | IG1 (BFB group) pre-BFB (20) | IG1 (BFB group) post-BFB (20) | Maximum NRS (0–10) pain during menstruation | −0.5 [−1.4/0.3]g | −0.2 [S]g | n.a. | |
37 | IG1 (BFB group) post-BFB (20) | No-treatment CG (17) | 0.6 [−2.18/0.74]g | −0.40 [S]g | p > 0.05 | ||
43 | IG1 (BFB group) post-BFB (20) | IG2 (rhythmical massage) post treatment (23) | −0.6 [−1.94/0.76]g | −0.23 [S]g | p > 0.05 | ||
Starr et al. 2013 [46] | 694 | Pre-BFB in pat. w urinary symptoms (694) | Post-BFB in pat. w urinary symptoms (n.a.) | % subjective global urinary symptom improvement since initial session (0: none–100%: perfect) | Mean 80–85% improvementh | n.a. | n.a. |
187 | Pre-BFB in pat. w bowl symptoms (187) | Post-BFB in pat. w bowl symptoms (n.a.) | % subjective global bowel symptom improvement since initial session (0: none–100%: perfect) | Mean 80–85% improvementh | n.a. | n.a. | |
368 | Pre-BFB in pat. w pelvic pain symptoms (368) | Post-BFB in pat. w pelvic pain symptoms (n.a.) | % subjective global pelvic pain symptom improvement since the initial session (0: none–100%: perfect) | Mean 50–90% improve-menth | n.a. | p > 0.05 | |
Lúcio et al. 2014 [47] | 6 | IG1 pre BFB, PFM training and sham-electro-stimulation (6) | IG1 post BFB, PFM training and sham electrostimulation (6) | Symptom score: FSFI subdomain pain | 1.6 | n.a. | p > 0.05b |
6 | IG1 pre BFB, PFM training and sham-electro-stimulation (6) | IG1 post BFB, PFM training and sham-electro-stimulation (6) | Symptom score: FSFI total score (2.0–36.0 = best) | −10 | n.a. | p < 0.05b | |
Aalaie et al. 2020 [48] | 9 | IG1 (BFB group) pre-treatment (10) | IG1 (BFB group) 3 months post-treatment (9) | Symptom score: FSFI subdomain pain | 0.9 [0.1;1.6]g | η2 = 0.66 [L]g | p = 0.026 |
20 | IG1 (BFB group) 3 months post-treatment (9) | IG2 (EGS) 3 months post-treatment (11) | – | n.a. | η2 = 0.01 [S]g | p = 0.985 | |
9 | IG1 (BFB group) pre-treatment (10) | IG1 (BFB group) 3 months post-treatment (9) | Symptom score: FSFI total score (2.0–36.0 = best) | 8.9 [7.0; 10.9]g | η2 = 0.96 [L]g | p < 0.001 | |
20 | IG1 (BFB group) 3 months post-treatment (9) | IG2 (EGS) 3 months post-treatment (11) | n.a. | η2 = 0.64 [L]g | p = 0.002 | ||
Chronic pelvic pain in children | |||||||
Hoebeke et al. 2004 [51] | 21 | n/a | Study group post BFB (21) | SR: % patients reporting complete pain relief | 80.95 | n.a. | n.a. |
21 | n/a | Study group long-term f/u (16 months) (21) | 66.67 | n.a. | n.a. | ||
Ebiloglu et al. 2016 [52] | 136 | Whole study group pre-BFB [136] | Whole study group post BFB (6 months) (136) | SR: % patients with dysuria | −19.85 | n.a. | p = 0.007c |
107 | Subgroup OBS and dysf. voiding pre-BFB (107) | Post BFB (6 months) in this subgroup (107) | −20.56 | n.a. | p < 0.001c | ||
29 | Subgroup OBS only pre-BFB (29) | Post BFB (6 months) in this subgroup (29) | −17.24 | n.a. | p < 0.001c | ||
136 | Whole study group pre-BFB (136) | Whole study group post BFB (6 months) (136) | Symptom score: LUTDSS | −8.2 | n.a. | p < 0.001c | |
Ergin et al. 2016 [53] | 39 | IG pat. w dysfunctional voiding pre-BFB in (52) | IG post BFB (6th month) (39) | SR: % patients with dysuria | −83.3 | n.a. | p = 0.063c |
39 | IG pat. w dysfunctional voiding pre-BFB (52) | IG post BFB (6th month) (39) | Symptom score: DVISSS | −8.3 | n.a. | p = 0.019 | |
Li et al. 2006 [54] | 25 | IG pat. w chronic prostatitis pre-BFB (25) | IG post BFB (after ~12 weeks) (25) | Symptom score: NIH-CPSI subdomain pain (0–21) | −2 | n.a. | p = 0.001b |
25 | IG pat. w chronic prostatitis pre-BFB (25) | IG post BFB (after ~12 weeks) (25) | Symptom score: NIH-CPSI total score (0–43) | −17 | n.a. | p < 0.001b | |
Musculoskeletal, low back pain, myofascial pain | |||||||
Kent et al. 2015 [55] | 58 | IG pre-BFB (58) | IG 3 months post-BFB (58) | Pain VAS (0–10) | −20.5 [−30.45;−10.55] | −0.87 [VL] | n.a. |
54 | IG pre-Guidelines Care (54) | IG 3 months post-Guidelines care (54) | −6.5 [−9.34;−3.61] | −0.98 [VL] | n.a. |
Study | n (total group 1, 2) | Group 1 (n1) | Group 2 (n2) | Outcome measure | MD: group 2 minus group 1 | 95% CI lower bound | 95% CI upper bound | Effect size [strength] | P-value (for difference in means) | |
---|---|---|---|---|---|---|---|---|---|---|
Constipation, dyssynergic defecation | ||||||||||
Ba-Bai-Ke-Re et al. 2014 [26] | 88 | IG1 (BFB) (44) | IG2 (laxatives) (44) | PAC-QoL 1 month post | 12.00 | 10.904 | 13.096 | 3.731 | H | p < 0.001a |
88 | IG1 (BFB) (44) | IG2 (laxatives) (44) | PAC-QoL 3 months post | 14.00 | 13.077 | 14.923 | 5.173 | H | p < 0.001a | |
88 | IG1 (BFB) (44) | IG2 (laxatives) (44) | PAC-QoL 6 months post | 16.00 | 15.299 | 16.701 | 7.784 | H | p < 0.001a | |
Zhu et al. 2011 [29] | 36 | Study group pre-BFB (36) | Study group post-BFB (36) | SF-36: physical functioning | 7.30 | −0.679 | 15.279 | 0.494 | S | p = 0.001a |
36 | Pre-BFB (36) | Post-BFB (36) | SF-36: role physical | 23.80 | 2.347 | 45.253 | 0.599 | M | p < 0.001a | |
36 | Pre-BFB (36) | Post-BFB (36) | SF-36: bodily pain | 10.30 | −1.301 | 21.901 | 0.479 | S | p = 0.001a | |
36 | Pre-BFB (36) | Post-BFB (36) | SF-36: vitality | 8.00 | −3.932 | 19.932 | 0.362 | S | p = 0.042a | |
36 | Pre-BFB (36) | Post-BFB (36) | SF-36: role emotional | 19.50 | 0.387 | 38.613 | 0.551 | M | p = 0.001a | |
36 | Pre-BFB (36) | Post-BFB (36) | SF-36: mental health | 11.00 | 0.368 | 21.632 | 0.559 | M | p = 0.003a | |
36 | Pre-BFB (36) | Post-BFB (36) | SF-36: social function | 10.90 | −0.701 | 22.510 | 0.507 | M | p = 0.014a | |
36 | Pre-BFB (36) | Post-BFB (36) | SF-36: general health | 10.50 | −1.705 | 22.704 | 0.465 | S | p = 0.008a | |
36 | Pre-BFB (36) | Post-BFB (36) | PAC-QOL: physical discomfort | −0.99 | −1.561 | −0.419 | −0.937 | L | p < 0.001a | |
36 | Pre-BFB (36) | Post-BFB (36) | PAC-QOL: psycho-social discomfort | −0.37 | −0.784 | 0.044 | −0.482 | S | p < 0.001a | |
36 | Pre-BFB (36) | Post-BFB (36) | PAC-QOL: worries, concerns | −0.98 | −1.420 | −0.540 | −1.201 | VL | p < 0.001a | |
36 | Pre-BFB (36) | Post-BFB (36) | PAC-QOL: satisfaction | −1.33 | −1.834 | −0.826 | −1.425 | VL | p < 0.001a | |
36 | Pre-BFB (36) | Post-BFB (36) | PAC-QOL: overall | −0.92 | −1.277 | −0.563 | −1.393 | VL | p < 0.001a | |
Male chronic pelvic pain syndrome, Urological Chronic Pelvic Pain Syndrome | ||||||||||
Cornel et al. 2005 [34] | 31 | Study group pre-BFB (31) | Study group post-BFB (31) | NIH-CPSI: QoL (0–12 points) | −3.80 | n.a. | n.a. | n.a. | n.a. | p < 0.001b |
Yang et al. 2017 [35] | 22 | IG1 (BFB + NMES) pretreatment (22) | IG1 12 weeks post-treatment (22) | NIH-CPSI: QoL | −5.20 | −7.523 | −2.870 | −1.564 | VL | p < 0.001a |
45 | BFB + NMES (22) | PEMF (23) | NIH-CPSI: QoL 12 wks post | 1.20 | −0.382 | 2.782 | 0.365 | S | p = 0.012a | |
He et al. 2009 [36] | 21 | Study group pre-BFB (21) | Study group 10 weeks post-BFB (21) | NIH-CPSI: life impact | −6.70 | −8.605 | −4.795 | −2.528 | H | p < 0.05b |
Female chronic pelvic pain | ||||||||||
Gentilcore-Saulnier et al. 2010 [40] | 11 | IG (provoked vestibulodynia) pre-BFB (11) | IG post-BFB (11) | Perceived impact on QoL (0 = no to 10 = worst) | −1.55 | −3.367 | 0.267 | −0.882 | L | p = 0.003a |
Bendana et al. 2009 [41] | 13 | Strudy group pre-BFB (52) | Study group 3 months post-BFB (13) | VAS (0–10) | −2.56 | n.a. | n.a. | n.a. | n.a. | p < 0.001a |
Vagedes et al. 2019 [45] | 20 | IG1 (BFB) pre-BFB (20) | IG1 post-BFB (20) | SF-12: mental score | 4.1c | −0.3c | 8.4c | 0.4c | S | n.a. |
20 | IG1 (BFB) pre-BFB (20) | IG1 post-BFB (20) | SF-12: physical score | 4.4c | 0.4c | 8.5c | 0.5c | S | n.a. | |
20 | IG1 (BFB) pre-BFB (20) | IG1 post-BFB (20) | SF-12: sum score | 8.7c | 3.5c | 13.8c | 0.6c | M | n.a. | |
37 | IG1 (BFB) post-BFB (20) | CG (usual care) (17) | SF-12: sum score | 6.13c | −3.09c | 15.35c | 0.41c | S | p > 0.05 | |
43 | IG1 (BFB) post-BFB (20) | IG2 (massage) post-treatment (23) | SF-12: sum score | −0.57c | −9.18c | 8.03c | −0.04c | VS | p > 0.05 | |
Chronic pelvic pain in children | ||||||||||
Li et al. 2006 [54] | 22 | IG patients with chronic prostatitis post-BFB (25) | IG post-BFB (22) | NIH-CPSI: life impact | 8 | n.a. | n.a. | n.a. | n.a. | p < 0.001b |
Study | Secondarily evaluated outcome measure | Domain, subgroup | f/u | IG pre-post | IG vs. IG /IG vs. CG | Significant improvement in subdomains, significant difference between IG/IG or IG/CG (p-value) | No significant improvement in subdomains or no significant difference between IG/IG, IG/CG (p-value) |
---|---|---|---|---|---|---|---|
Anorectal pain syndrome | |||||||
Chiarioni et al. 2010 [16] | Anorectal manometry | IG1 BFB group: patients with high likely LAS | Baseline–1 month | x | – | Anal pressure with straining (% relaxing), balloon defecation (% successful), urge threshold (ml), maximum tolerable volume (ml), compliance (mm Hg) (p < 0.025) | Resting anal canal pressure (mm Hg), rectoanal inhibitory reflex threshold (ml) (p ≥ 0.025) |
Baseline–3 month | x | – | Anal pressure with straining (% relaxing), balloon defecation (% successful), rectoanal inhibitory reflex threshold (ml), urge threshold (ml), maximum tolerable volume (ml) (p < 0.025) | Resting anal canal pressure (mm Hg), compliance (mm Hg) (p ≥ 0.025) | |||
IG1 BFB group: patients with possible LAS | Baseline—1 month, baseline—3 months | x | – | Anal pressure with straining (% relaxing), balloon defecation (% successful) (p < 0.025) | Resting anal canal pressure (mm Hg), rectoanal inhibitory reflex threshold (ml), urge threshold (ml), maximum tolerable volume (ml), compliance (mm Hg) (p < 0.025) | ||
IG1 BFB group (n = 52) vs. IG2 EGS (n = 52) or IG3 massage group (n = 53) (in favour of BFB) in patients with high likely LAS | After 1 month, after 3 months | – | x | Anal pressure with straining (% relaxing), balloon defecation (% successful) (p < 0.025) | Resting anal canal pressure (mm Hg), rectoanal inhibitory reflex threshold (ml), urge threshold (ml), maximum tolerable volume (ml), compliance (mm Hg) (p < 0.025) | ||
Heah et al. 1997 [17] | Anorectal manometry | Study group (n = 16) | Baseline—after treatment | x | – | None (p < 0.052) | Anal canal mean resting/maximum squeeze pressure (mm Hg), rectum volume first sensation (ml)/maximum tolerable volume (ml)/compliance (ml/mm Hg), perineal descent rest/strain (cm) (p > 0.05) |
Grimaud et al. 1991 [20] | Anorectal manometry | Study group (n = 12) | Baseline—after treatment | x | – | Anal canal resting pressure (mm Hg), p < 0.01 (no significant difference any more compared to healthy controls without BFB intervention) | – |
Constipation, dyssynergic defecation | |||||||
Chiarioni et al. 2006 [21] | Anorectal manometry | BFB group (n = 54/109) | Baseline—6 months, baseline—12 months after starting treatment | x | – | Increased anal pressure (n, %), (paradoxical) EMG increase (n, %), unable to evacuate balloon (n, %), anal squeeze pressure (mm Hg), rectoanal inhibitory reflex threshold (ml), urge threshold (ml), maximum tolerable volume (ml), compliance (mm Hg) (p < 0.01) | Anal resting pressure (mm Hg) (p ≥ 0.01) |
Baseline—24 months after starting treatment | x | – | Increased anal pressure (n, %), (paradoxical) EMG increase (n, %), unable to evacuate balloon (n, %), anal squeeze pressure (mm Hg), urge threshold (ml), maximum tolerable volume (ml) (p < 0.01) | Anal resting pressure (mm Hg), rectoanal inhibitory reflex threshold (ml), compliance (mm Hg) (p ≥ 0.01) | |||
BFB group vs. laxative group, in favour BFB group (n = 109) | 6 and after 12 months after starting treatment | – | x | Increased anal pressure (n, %), (paradoxical) EMG increase (n, %), unable to evacuate balloon (n, %) (p < 0.01) | Anal resting pressure (mm Hg), anal squeeze pressure (mm Hg), rectoanal inhibitory reflex threshold (ml), urge threshold (ml), maximum tolerable volume (ml), compliance (mm Hg) | ||
24 months after starting treatment | – | x | No parameter (p < 0.01) | All parameters (p ≥ 0.01) | |||
Koutsomanis et al. 1994 [22] | Anorectal manometry | Study group (n = 20) | Baseline—after treatment | x | – | Paradoxical contraction on evacuation straining (n pre: n = 15/20, n post: n = 0/20, (p : n.a.)) | Anal resting pressure, anal squeeze pressure, anorectal sensation (p : n.a.) |
Battaglia et al. 2004 [24] | Anorectal manometry | Patients with PF dyssynergia (n = 14/24) | Baseline—3 months after treatment | x | – | Sensation threshold (mm Hg; p = 0.042), paradoxical increase in intra-anal pressure during straining (p : n.a.) | Maximum basal pressure of internal anal sphincter, maximum rectum tolerable volume (p ≥ 0.05) |
Patients with slow transit (n = 10/24) | Baseline—3 months after treatment | x | – | Maximum rectum tolerable volume (ml), (p = 0.008) | Maximum basal pressure of internal anal sphincter (mm Hg), sensation threshold (mm Hg) (p ≥ 0.05) | ||
Wang et al. 2003 [25] | Anorectal manometry | Study group (n = 50) | Baseline—after treatment | x | – | Anal canal average rest pressure (mm Hg) rectum: initial sense (ml), (p < 0.05) | Anal canal voluntary squeeze (mm Hg), rectum: maximum tolerable volume (ml) and compliance (ml/mm Hg), (p ≥ 0.05) |
Ba-Bai-Ke-Re et al. 2014 [26] | Anorectal manometry | BFB group vs. laxative group, in favor BFB group (n = 88) | Baseline—after treatment | – | x | Anorectal resting pressure, anorectal squeeze pressure (mm Hg) (p < 0.05) | – |
Chiarioni et al. 2005 [28] | Gut transit time | PF dyssynergia (n = 34) vs. slow transit only (n = 12) | Baseline—1/6/12/24 months after treatment | – | x | % of patients with abnormal transit test: baseline: 100%; at all f/u: PF dyssynergia vs. slow-transit-only: sign. smaller % of patients with abnormally delayed transit, p < 0.05 | – |
Balloon defecation test | Patients with PF dyssynergia (n = 34) | Baseline—after treatment (1, 6, 12, 24 months) | x | – | Baseline: 0%, after treatment (1–24 months): 82–85% could defecate the balloon within 5 min (p : n.a.) | – | |
Anorectal manometry | Patients with PF dyssynergia (n = 34) | Baseline—after treatment (1, 6 months) | x | – | Urge threshold (ml), maximum tolerable pressure (mm Hg), straining rectal pressure (mm Hg), dyssynergia (balloon defecation test) (p < 0.05) | Anal canal resting pressure (ml), rectoanal inhibitory reflex threshold (ml), compliance (mm Hg100ml) p ≥ 0.05 | |
Patients with slow transit only (n = 12) | Baseline—after treatment (1, 6 months) | x | – | Urge threshold (ml) (p < 0.05) | Anal canal resting pressure (ml), rectoanal inhibitory reflex threshold (ml), maximum tolerable pressure (mm Hg), compliance (mm Hg100ml), straining rectal pressure (mm Hg) (p ≥ 0.05) | ||
Patients with PF dyssynergia (n = 34) vs. slow transit only (n = 12) in favour of PF dyssynergia | After 1, 6 months | – | x | Rectoanal inhibitory reflex threshold (ml; only after 1 month), after 1, 6 months: urge threshold (ml), maximum tolerable pressure (mm Hg), p < 0.01 | Rectoanal inhibitory reflex threshold (ml, only after 6 months), after 1, 6 months: anal canal resting pressure (ml), rectoanal inhibitory reflex threshold (ml, only after 6 months), compliance (mm Hg100ml), straining rectal pressure (mm Hg) (p ≥ 0.01) | ||
Parker et al. 2019 [31] | Anorectal manometry | Whole study group (constipation, fecal incontinence, rectal pain) (n = 130) | Baseline—after treatment | x | – | Resolved dyssynergic manometric pressure profile, balloon expulsion test < 1 min in n = 27/130, (p : n.a.) | – |
Constipation + dyssynergic defecation (n = 33/130) | Baseline—after treatment | x | – | Resolved dyssynergic manometric pressure profile, balloon expulsion test < 1 min in n = 13/53, (p : n.a.) | – | ||
Constipation without dyssynergic defecation (n = 3/130) | Baseline—after treatment | x | – | Improvement in anorectal manometry profile (resolved dyssynergic manometric pressure profile, balloon expulsion test < 1 min) in n = 2/3, (p : n.a.) | – | ||
Rectal pain (n = 3/130) | Baseline—after treatment | x | – | Resolved dyssynergic manometric pressure profile, balioon expulsion test < 1 min in n = 2/3, (p : n.a.) | – | ||
Male chronic pelvic pain syndrome, Urological Chronic Pelvic Pain Syndrome | |||||||
Cornel et al. 2005 [34] | Levator ani EMG | Study group (n = 18) | Baseline—after treatment | x | – | Mean pelvic muscle tonus↓ (mcV, p < 0.0012) | – |
He et al. 2010 [36] | Urodynamics (uroflowmetry + EMG) | Study group (n = 21) | Baseline—10 wks after treatment | x | – | Max. flow rate (ml/s), max. detrusor pressure-storage phase (cmH2O), max. urethra closure pressure (cmH2O), max. urethral pressure (cmH2O) (p < 0.05) | – |
Female chronic pelvic pain | |||||||
Glazer et al. 1995 [38] | PF EMG | Study group (n = 33) | Baseline—after treatment (=after 6th assessment) | x | – | Muscle contractile strength = mean contraction amplitude (mcV) ↑, mean relaxation amplitude ↓ (mcV) (p < 0.0001), SD: measure of the stability of the muscle at rest improved (p : n.a.) | – |
McKay et al. 2001 [39] | PF EMG | Study group (n = 29) | After 1 month—after 6 months | x | – | Mean maximum contractile strength ↑ (mcV): after 1st month: 16.42 in n = 29, after 6th month: 42.73 in n = 11 (dropout n = 18), (p : n.a.) | – |
Gentilcore-Saulnier et al. 2010 [40] | PF EMG | IG (provoked vestibulodynia, n = 11) | Baseline—after treatment | x | – | – | Tonic surface EMG resting activity: deep (p = 0.86) or superficial (p = 0.32) PF muscle layer |
Baseline—after treatment | x | – | – | PF muscle maximum voluntary contractile activity: deep: p = 0.82; superficial: p = 0.50 | |||
Baseline—after treatment | x | – | Superficial PFM EMG activity pain responses ↓ (mcV), (p < 0.0001) | Deep PF layer EMG activity pain response (mcV), (p = 0.72) | |||
IG (provoked vestibulodynia, n = 11) vs. healthy CG (n = 11) | Baseline, pretreatment | – | x | Sign. greater superficial PFM EMG activity pain responses (mcV) in pretreatment IG compared to CG (p = 0.003); sign. higher tonic activity in superficial PFM in pretreatment IG compared to CG (p = 0.04) | No sign. difference pretreatment IG vs. CG for: PFM maximum voluntary contractile activity for deep (p = 0.81) and superficial (p = 0.36) PFM; EMG pain responses of the deep PFM (p = 0.89); deep PFM tonic activity (p = 0.18) | ||
IG (provoked vestibulodynia, n = 11) vs. healthy CG (n = 11) | After treatment | – | x | – | No sign. difference between posttreatment IG and CG: tonic surface EMG resting activity at both superficial (p = 0.82) and deep (p = 0.31) PFM; PFM maximum voluntary contractile activity for deep (p = 0.54) and superficial (p = 0.90) PFM; EMG activity pain response (mcV) for deep (p = 0.98) or superficial (p = 0.18) PFM | ||
Digital intravaginal assessment | IG (n = 11 with pelvic floor dyssynergia) | Baseline—after treatment | x | – | PFM tone ↓ (p < 0.001), PFM flexibility ↑ (p = 0.01), PFM post-contraction relaxation capacity ↑ (p = 0.05), PFM strength ↑ (p = 0.04) | – | |
IG (n = 11 with provoked vestibulodynia) vs. healthy CG (n = 11) | Baseline | – | x | Pretreatment PVD group vs. CG: PFM tone: sign. higher in PVD group (p = 0.005), PFM flexibility: sign. lower in PVD group (p = 0.01), PFM relaxation: sign. less ability to relax PFM in PVD group (p = 0.02) compared to CG | Pretreatment PVD group vs. CG: no significant difference in PFM strength (p = 0.54) | ||
IG (n = 11 patients with provoked vestibulodynia) vs. healthy CG (n = 11) | After treatment | – | x | – | posttreatment PVD group vs. CG: no sign. difference in PFM tone (p = 0.30), PFM flexibility (p = 1.00), PFM relaxation (p = 0.47), PFM strength (p = 0.12) | ||
Philips et al. 1992 [42] | Perivaginal EMG | IG 1 (BFB group, n = 10) | Baseline—after treatment | x | – | – | Mean EMG scores (seated to void, tensing, relaxing, voiding; mcV) p > 0.05 |
Bennink et al. 1982 [44] | EMG lower abdomen | IG1 (n = 5) vs. IG2 (n = 5) | – | – | x | BFB group maintained a significantly lower level of EMG muscle tone (mcV/s) of lower abdomen on 1st day of menstruation compared to massage group (p < 0.05) | – |
Vagedes et al. 2019 [45] | Heart rate variability | BFB group (n = 20) | Baseline—after treatment | x | – | – | SDNNl, RMSSD, LF/HF ratio (p > 0.05) |
BFB (n = 20) vs. CG (n = 17)/BFB vs. massage (n = 23) | After treatment | – | x | – | Same values: BFB vs. CG/massage vs. BFB group post treatment: p > 0.05 | ||
Lúcio et al. 2014 [47] | Intravaginal digital examination | IG1: EMG BFB + PF training + sham NMES (n = 6) | Baseline—after treatment | x | – | PF muscle function according to PERFECT scheme ↑ [69]: power (0–5 = max. strength), endurance (sec), dynamic endurance (no. of repetitions), fast contractions (no. of repetitions): p < 0.05 | PF muscle palpation score: PF muscle tone (score: −3 to +3 = very hypertonic), flexibility (score 0–4 = very flexible), ability to relax PF muscles (Score 0–4 = spastic): p > 0.05 |
Chronic pelvic pain in children | |||||||
Ebiloglu et al. 2016 [52] | Urodynamics | Study group (n = 136) | Baseline—after treatment (6 months) | x | – | No. of patients with positive perineal EMG activity while urinating (p < 0.001) | – |
Urodynamics | Study group (n = 136) | Baseline—after treatment (6 months) | x | – | Mean voided volume (ml, p = 0.019), mean maximum flow rate (ml/s, p = 0.012) | Mean average flow rate (ml/s, p = 0.209), mean voiding time (s, p = 0.345), post-void residual volume (ml, p = 0.374) | |
Ergin et al. 2016 [53] | Urodynamics | Intervention group (n = 39) | Baseline—after treatment (6 months) | x | – | Uroflowmetry—EMG, post-void residual volume (p < 0.001) | – |
Li et al. 2006 [54] | Urodynamics | IG (n = 25) | Baseline—after treatment | x | – | Maximum urinary flow rate (ml/s), p = 0.001 | Postvoid residual urine volume (ml), p = 0.08 |
Data synthesis
Quality assessment
Results
Study selection
Study characteristics
Quality assessment
Study | Study design | Was the purpose stated clearly? | Was relevant background literature reviewed? | Was the sample described in detail? | Was sample size justified? | Were the outcome measures reliable? | Were the outcome measures valid? | Intervention was described in detail? | Contamination was avoided? | Cointerventiona was avoided? | Results were reported in terms of statistical significance? | Were the analysis method(s) appropriate? | Clinical importance was reported? | Drop-outs were reported? | Conclusions were appropriate given study methods and results? | Total score (sum score) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anorectal pain syndrome | ||||||||||||||||
Chiarioni et al. 2010 [16] | RCT, 3 arms | Yes | Yes | Yes | Yes | N.add.a | N.add.a | Yes | Yes | No | Yes | Yes | Yes | No | Yes | 10 |
Heah et al. 1997 [17] | Non-RCT | Yes | Yes | No | No | N.add.a | N.add.a | Yes | N/A | No | Yes | Yes | Yes | No | Yes | 7 |
Ger et al. 1993 [18] | Non-RCT | Yes | Yes | Yes | No | N.add. | N.add. | Yes | No | N.add. | No | No | Yes | Yes | Yes | 7 |
Gilliland et al. 1997a [19] | Non-RCT, retrospective | Yes | Yes | Yes | No | N.add. | N.add. | No | N/A | N.add. | Yes | Yes | Yes | Yes | Yes | 8 |
Grimaud et al. 1991 [20] | Non-RCT | Yes | Yes | Yes | No | N.add.a | N.add.a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 11 |
Constipation | ||||||||||||||||
Chiarioni et al. 2006 [21] | RCT, 2 arms | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes | 13 |
Koutsomanis et al. 1994 [22] | Non-RCT | Yes | Yes | No | No | N.add.a | N.add.a | Yes | N/A | No | Yes | Yes | Yes | Yes | No | 7 |
Chiotakakou-Faliakou et al. 1998 [23] | Non-RCT, retrospective | Yes | Yes | Yes | No | N.add. | N.add. | Yes | N/A | No | Yes | Yes | Yes | Yes | Yes | 9 |
Battaglia et al. 2004 [24] | Non-RCT | Yes | Yes | Yes | No | N.add.a | N.add.a | Yes | N/A | No | Yes | Yes | Yes | No | Yes | 8 |
Wang et al. 2003 [25] | Non-RCT | Yes | Yes | Yes | No | N.add.a | Yes | Yes | Yes | No | Yes | Yes | Yes | No | Yes | 10 |
Ba-Bai-Ke-Re et al. 2014 [26] | RCT, 2 arms | Yes | Yes | no | Yes | N.add.a | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes | 11 |
Roy 2000 [27] | Non-RCT, retrospective | Yes | Yes | Yes | No | N.add. | N.add. | Yes | N/A | No | Yes | Yes | Yes | No | Yes | 8 |
Chiarioni et al. 2005 [28] | Non-RCT | Yes | Yes | Yes | No | N.add.a | N.add.a | Yes | N/A | No | Yes | Yes | Yes | Yes | Yes | 9 |
Zhu et al. 2011 [29] | Non-RCT | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A | No | Yes | Yes | Yes | Yes | No | 11 |
Gilliland et al. 1997b [30] | Non-RCT, retrospective | Yes | Yes | Yes | No | N.add. | N.add. | No | N/A | No | Yes | Yes | Yes | Yes | No | 7 |
Parker et al. 2019 [31] | Non-RCT, retrospective | Yes | Yes | No | No | N.add. | No | No | N/A | N.add. | No | No | Yes | Yes | Yes | 5 |
Male chronic pelvic pain syndrome, Urological Pelvic Pain Syndrome | ||||||||||||||||
Clemens et al. 2000 [32] | Non-RCT | Yes | Yes | No | No | N.add. | N.add. | Yes | N/A | N.add. | Yes | Yes | Yes | Yes | Yes | 8 |
Cornel et al. 2005 [34] | Non-RCT | Yes | Yes | Yes | No | Yes | Yes | Yes | N/A | N.add. | Yes | Yes | Yes | Yes | Yes | 11 |
Yang et al. 2017 [35] | Non-RCT, retrospective | Yes | Yes | Yes | No | N.add.a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 12 |
He et al. 2010 [36] | Non-RCT, retrospective | Yes | No | No | No | N.add.a | N.add.a | No | N/A | Yes | Yes | Yes | Yes | No | Yes | 6 |
Female chronic pelvic pain | ||||||||||||||||
Schmitt et al. 2017 [37] | Non-RCT | Yes | Yes | No | No | N.add.a | Yes | Yes | N/A | N.add. | Yes | Yes | Yes | Yes | Yes | 9 |
Glazer et al. 1995 [38] | Non-RCT | No | Yes | Yes | No | N.add.a | N.add.a | Yes | N/A | No | Yes | Yes | Yes | No | Yes | 7 |
McKay et al. 2001 [39] | Non-RCT | Yes | Yes | Yes | No | N.add.a | N.add.a | Yes | N/A | N.add. | Yes | Yes | Yes | Yes | Yes | 9 |
Gentilcore-Saulnier et al. 2010 [40] | Non-RCT | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A | Yes | Yes | Yes | Yes | No | Yes | 12 |
Bendana et al. 2009 [41] | Non-RCT, retrospective | Yes | Yes | Yes | No | N.add. | No | Yes | N/A | N.add. | Yes | Yes | Yes | Yes | Yes | 9 |
Philips 1992 [42] | RCT | Yes | Yes | Yes | No | N.add.a | N.add.a | No | Yes | N.add. | Yes | Yes | Yes | No | Yes | 8 |
Hart et al. 1981 [43] | Non-RCT, 2 arms | Yes | Yes | Yes | No | N.add. | N.add. | Yes | Yes | N.add. | Yes | N.add. | Yes | Yes | No | 8 |
Bennink 1982 [44] | RCT, 3 arms | Yes | Yes | No | No | N.add. | N.add. | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | 9 |
Vagedes et al. 2019 [45] | RCT, 3 arm | Yes | Yes | Yes | Yes | Yes | N.add.a | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes | 12 |
Starr et al. 2013 [46] | Non-RCT, retrospective | Yes | Yes | Yes | Yes | N.add. | No | Yes | N/A | No | Yes | Yes | Yes | Yes | Yes | 10 |
Lúcio et al. 2014 [47] | RCT, 3 arms | Yes | Yes | Yes | No | N.add.a | Yes | Yes | Yes | N.add. | Yes | Yes | Yes | Yes | Yes | 11 |
Aalaie et al. 2020 [48] | RCT, 2 arms | Yes | Yes | Yes | Yes | Yes | N.add.a | Yes | Yes | N.add. | Yes | Yes | Yes | Yes | Yes | 12 |
Chronic pelvic pain in children in children | ||||||||||||||||
Hoebeke et al. 2004 [51] | Non-RCT | Yes | Yes | Yes | No | N.add. | N.add. | Yes | N/A | No | No | N.add. | Yes | No | No | 5 |
Ebiloglu et al. 2016 [52] | Non-RCT, retrospective | Yes | Yes | Yes | Yes | N.add.a | N.add.a | Yes | N/A | N.add. | Yes | Yes | Yes | No | Yes | 9 |
Ergin et al. 2016 [53] | Non-RCT | Yes | Yes | Yes | No | N.add.a | Yes | No | N/A | N.add. | Yes | Yes | Yes | Yes | Yes | 9 |
Li et al. 2006 [54] | Non-RCT | Yes | Yes | Yes | No | N.add.a | Yes | No | N/A | Yes | Yes | Yes | Yes | Yes | Yes | 10 |
Musculoskeletal, low back pain, myofascial pain | ||||||||||||||||
Kent et al. 2015 [55] | RCT, 2 arms | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes | 13 |
Criteria | Eligibility criteria and source | Random allocation | Concealed allocation | Baseline comparability | Blinding of subjects | Blinding of therapists | Blinding of assessors | Adequate follow-up (>85%) | Intention-to-treat analysis | Between-group statistical comparisons | Reporting of point measures and measures of variability | Total score | Quality |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chiarioni et al. 2010 [16] | Yes | Yes | Yes | Yes | No | No | Yes | Yes | Yes | Yes | Yes | 8 | Good |
Chiarioni et al. 2006 [21] | Yes | Yes | Yes | Yes | No | No | Yes | No | No | Yes | Yes | 6 | Good |
Ba-Bai-Ke-Re et al. 2014 [26] | Yes | Yes | No | Yes | No | No | No | No | Yes | Yes | Yes | 5 | Fair |
Philips et al. 1992 [42] | Yes | Yes | No | Yes | No | No | Yes | Yes | Yes | Yes | Yes | 7 | Good |
Bennink et al. 1982 [44] | Yes | Yes | No | Yes | No | No | No | Yes | Yes | Yes | Yes | 6 | Good |
Vagedes et al. 2019 [45] | Yes | Yes | Yes | Yes | No | No | No | No | Yes | Yes | Yes | 6 | Good |
Lúcio et al. 2014 [47] | No | Yes | No | Yes | Yes | No | Yes | No | No | Yes | Yes | 6 | Good |
Aalaie et al. 2020 [48] | Yes | Yes | Yes | Yes | No | No | No | Yes | Yes | Yes | Yes | 7 | Good |
Kent et al. 2015 [55] | Yes | Yes | No | Yes | No | No | No | No | Yes | Yes | Yes | 5 | Fair |
Participants
Intervention
Outcome
Effect of biofeedback interventions on pain, overall symptoms
Effect of biofeedback interventions on quality of life
Effect of biofeedback interventions on physiological parameters
Discussion
Quality
Efficacy of biofeedback in certain phenotypes and existing recommendations of guidelines
Pros and cons of biofeedback in pelvic pain conditions and criteria to improve treatment success
Limitations of the present review
Conclusion
Implications for future research
-
conduct a systematic literature review using MeSH terms that more thoroughly evaluate the effect of biofeedback therapy in a certain phenotype (e.g. anorectal disorders, urological chronic pelvic pain syndrome, bladder pain syndrome, gynecologic pelvic pain conditions);
-
list the term “pelvic pain” in the keywords of studies on certain pelvic pain subtypes so that these trials are detected by a literature search on the umbrella term (as chronic pelvic pain comprises many phenotypes);
-
improve the quality of future studies, e.g. by choosing an RCT study design that is based on a sample size calculation, performing a post hoc analysis or a correction for multiple testing;
-
report on the effect size and an estimate of their precision such as the confidence interval to describe the clinical relevance of results;
-
conduct future trials with more homogeneous outcome assessment (to allow future meta-analysis). Ideally, validated questionnaires or pain scales should be used to measure outcome. For stating success rates, an international consensus on the graduation of these rating scales would be beneficial to standardize outcome and improve comparability between study results;
-
continue to evaluate the optimum type and extent of biofeedback interventions for the certain phenotypes;
-
evaluate changes in quality of life and psychological parameters, such as anxiety and depression (as psychological disorders are common comorbidities in patients with chronic pain conditions).