Efficacy and Complications of the Adjustable Sling System ArgusT for Male Incontinence: Results of a Prospective 2-Center Study

doi:10.1016/j.urology.2014.10.019

Urology

Volume 85, Issue 2, February 2015, Pages 316-320

https://doi.org/10.1016/j.urology.2014.10.019 Get rights and content

Objective

To evaluate prospectively the efficacy and the safety of the ArgusT in male patients with persistent stress urinary incontinence.

Methods

A prospective 2-center evaluation was conducted on consecutive patients treated for persistent stress incontinence. Forty-two patients were implanted with the ArgusT male sling system with no associated surgery. Measurements included daily pad usage, 24-hour pad weight test, International Quality of Life questionnaire, International Consultation on Incontinence Questionnaire short form, and the Patient Global Impression of Improvement. Postoperative complications were assessed using the Clavien-Dindo classification. The definitions used were cured, 0-5 g in 24-hour pad weight test; improved, reduction of urine loss in 24-hour pad weight test >50%; and failed, all others.

Results

After a mean follow-up of 28.8 months (20-38 months), 26 patients were dry (61.9%) with a pad test of 0-5 g/24 hours. Eleven patients (26.2%) improved. Five patients are considered failures. Overall daily pad use, urine loss in the 24-hour pad test, and quality of life scores improved significantly after sling implantation. Median adjustment rate was 1.7. There were no perioperative complications. Postoperative complications were mainly grade I and II complications according to the Clavien-Dindo classification.

Conclusion

The ArgusT sling system offers an effective and safe treatment option for male patients with moderate to severe stress urinary incontinence in a follow-up >2 years, even after radiotherapy.

Section snippets

Population

Between January 2011 and February 2012, 42 consecutive male patients with persistent SUI (according to the International Continence Society classification⁸) after prostate surgery were treated with the adjustable ArgusT sling in a prospective, sequential, clinical study. Sling implantation was performed a minimum of 6 months after prostate surgery or additional adjuvant radiotherapy.

Inclusion criteria were as follows: age ≥40 years and persistent SUI after prostate surgery with stable

Results

After a mean follow-up of 28.8 months (median, 28.5 months [20-38 months]), 26 patients were dry (61.9%) without using pads and with a pad test of 0-5 g/24 hours, and 11 patients (26.2%) improved. In total, 5 patients (11.9%) failed, 3 because of ineffectiveness and 2 because of persistent PP or IP.

Pad weight in the 24-hour pad test and the daily pad use decreased significantly.

ICIQ-UI SF score decreased, and I-QOL score increased significantly.

Change of PVR was not significant.

Detailed

Comment

Until now, only published studies for the classic ARGUS system (retropubic approach) and 1 published case report of the ArgusT system are available.2, 3, 4, 5, 6, 7, 12 Reported continence rate for the ARGUS Classic is 17%-79% in a maximum follow-up of up to 45 months. In general, one-third of the patients need readjustments. Reported complications of the ARGUS Classic include acute urinary retention, sling removal (up to 12%, due to urethral, bladder, or abdominal wall erosion; infections;

Conclusion

In a midterm follow-up, the ArgusT sling system appears to be a safe treatment alternative for male patients with persistent SUI. Age, BMI, and additional radiotherapy seem to have no negative impact on outcome. Implantation of the artificial urinary sphincter after failed ArgusT is safe and shows good results comparable with primary implantation.

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Cited by (37)

Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis
2020, European Urology Focus
Citation Excerpt :
Six studies were included after checking the reference lists. Finally, 64 studies with 72 patient cohorts were included in the meta-analysis synthesis [9–72]. Figure 1 shows the detailed study selection process.
Male slings are recommended by the European Association of Urology guideline for the treatment of mild to moderate postprostatectomy incontinence. However, none of them has been proved to be superior to the others, and there are no defined guidelines to preference of a given sling model.
To evaluate and compare the efficacy and safety of the different types of male slings in the treatment of postprostatectomy incontinence.
This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. A systematic literature search in the databases of PubMed, Embase, and Cochrane using the keywords “incontinence,” “prostatectomy,” and “male sling/system” was conducted in June 2018. Studies in English with at least 15 patients and a minimum follow-up of 12 mo were included. As the primary endpoint, we assessed the cure rate of the different sling types. As secondary endpoints, we assessed the improvement rate, subjective cure rate, overall complication rate, explantation rate, risk factors for failure, and effect on patients’ quality of life.
The literature search identified 833 articles. A total of 64 studies with 72 patient cohorts were eligible for inclusion. Fixed slings were implanted in 55 (76.4%) of the patient cohorts. The objective cure rate varies between 8.3% and 87% (pooled estimate 0.50, 95% confidence interval [CI] 0.45–0.56, I² = 82%). Subjective cure was achieved in 33–94.4%. Adjustable slings showed objective cure rates between 17% and 92% (pooled estimate 0.61, 95% CI 0.51–0.71, I² = 88%). The subjective cure rate varies between 28% and 100%. In both types of slings, pain was the most common complication, but chronic painful conditions were really rare (1.3% in fixed slings and 1.5% in adjustable slings). The most common complication after pain was urinary retention in fixed slings, and infection and consequential explantation in adjustable slings.
Both fixed and adjustable slings are beneficial for the treatment of postprostatectomy incontinence. Although adjustable slings might lead to higher objective cure rates, they might be associated with higher complication and explantation rates. However, at present, due to significant heterogeneity of the data, this cannot be said with certainty. More randomized controlled trials with long-term follow-up and the same definition for continence are needed.
Fixed and adjustable slings are effective treatment options in mild to moderate postprostatectomy incontinence.
Argus-T Sling in 182 Male Patients: Short-term Results of a Multicenter Study
2017, Urology
Citation Excerpt :
These results are also confirmed by Romano et al with a cure rate of 100% in subjects with mild and moderate PPI, whereas 71% in severe PPI.10 The lower efficacy of Argus-T in presence of severe incontinence confirms what was previously described in literature9,17,20 where AUS remains the “gold standard,” whereas the ideal candidates for male sling are patients with mild and moderate PPI. Rehder et al21 obtained the same conclusion with AdVance, reporting a continence rate of 71% in patients with severe PPI compared with 79% in patients with lower incontinence degree.
To evaluate the short-term results with Argus-T sling in patients with post-prostatectomy incontinence (PPI).
A total of 182 patients with PPI were treated with Argus-T sling at 5 urologic centers from June 2008 to March 2013. The preoperative evaluation included medical history, pad count (1-2 pads: mild PPI; 3-5 pads: moderate PPI; >5 pads: severe PPI), visual analog scale on continence, quality of life score scale, physical examination, cystoscopy, and urodynamic evaluation.
Postoperative evaluation was performed 6 weeks postoperatively, and late follow-up was achieved in April 2013. We considered a successful result when patients were cured (0-1 pads/24 hours) and or improved (1-2 pads/24 hours or a reduction in pad per day usage greater than 50%).
Twenty-one (11.8%), 96 (52.7%), and 65 (35.7%) patients have mild, moderate, and severe incontinence, respectively. At the median follow-up of 22 months, the overall success rate was 86.2%. We obtained successful results of 95% in mild incontinence, 78% in moderate incontinence and 70% in severe incontinence. In cured and improved patients, we observed a statistically significant amelioration of quality of life (P <.0001).
Sling regulation was carried out in 42.9% of cases, whereas its removal occurred in 9.3% of cases. Postoperative complications were reported in 14.3% of patients. In patients with previous radiotherapy, we observed a successful result in 61.2% of cases.
This study represents the first report that shows short-term results of Argus-T positioning in a large population. Argus-T seems to offer good outcomes in patients with mild and moderate PPI.
The Adjustable Transobturator Male System in Stress Urinary Incontinence After Transurethral Resection of the Prostate
2017, Urology
Citation Excerpt :
Recently, male slings became popular for treatment of mild-to-moderate PPI whereas the AUS is still the gold standard, in particular, severe SUI and superior after failed male slings.17,18 Concerning PPI, male slings achieve treatment success rates of 32%-90% depending on the device, the surgery approach, the follow-up period, and the patient risk profile.4,9,19-21 Identified risk factors for failure of adjustable and nonadjustable devices are nearly the same and include pelvic RT, severe SUI, urinary infection, poor patient performance, prior continence surgery, preoperatively low bladder capacity, and overactive bladder symptoms.12,22-24
To investigate the efficacy and safety of the Adjustable Transobturator Male System (ATOMS) in men with stress urinary incontinence after transurethral resection of the prostate (TURP).
From a large international prospectively administrated ATOMS register, we identified 49 patients with an ATOMS device as a result of persistent stress urinary incontinence after TURP. For evaluation, the men were divided into standard transurethral resection of the prostate (sTURP) and palliative transurethral resection of the prostate (pTURP) in radiated patients. Baseline and follow-up measurements included continence parameters, urodynamics, quality-of-life surveys (Patient Global Impression-Improvement and International Consultation on Incontinence Questionnaire-Short Form), and pain ratings. The dry rate (0-1 security pad/<10 mL urine loss), the success rate (overall improvement), removals, complications, and treatment failures were recorded. A P value of <.05 was considered statistically significant.
After a median of 34 and 22 months' follow-up and 2-3 adjustments, the sTURP and pTURP cohorts had 58% and 50% dry rates and 90% and 87% success rates. Hence, no improvement was seen in 10% and 13%. The removal rate was higher in pTURP (50% vs 10%, P = .0171) and infection was the most common side effect (50%) observed. Neither intraoperative nor Clavien-Dindo 4 and 5 adverse events were recorded. In sTURP and pTURP, the median daily pad count and the pad test improved significantly (all P <.001), and quality-of-life parameters shifted to a high satisfaction level (P <.001 and P = .001). Urodynamics remained unchanged and postoperative pain was not an issue.
The ATOMS device shows promising treatment outcomes in patients after TURP and a similar efficacy as in postprostatectomy incontinence. There is no difference in continence outcome between sTURP and pTURP; however, a higher removal rate was found after pTURP, which may be important for patient counseling.
Use of implants to treat male urinary incontinence
2023, Aktuelle Urologie
Management of Urinary Incontinence Following Radical Prostatectomy: Challenges and Solutions
2023, Therapeutics and Clinical Risk Management
Post-prostatectomy incontinence in patients with adjuvant radiotherapy: is there a therapeutic space for transobturator sling?
2022, Pelviperineology

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: Financial Disclosure: Ricarda M. Bauer and Wilhelm Huebner declare consultancy work, lectures, and participation in clinical trials for Promedon. The remaining authors declare that they have no relevant financial interests.

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Female UrologyEfficacy and Complications of the Adjustable Sling System ArgusT for Male Incontinence: Results of a Prospective 2-Center Study

Objective

Methods

Results

Conclusion

Section snippets

Population

Results

Comment

Conclusion

J Urol

J Urol

J Urol

Urology

Urology

J Urol

Adjustable bulbourethral male sling: experience after 101 cases of moderate-to-severe male stress urinary incontinence

BJU Int

Female Urology
Efficacy and Complications of the Adjustable Sling System ArgusT for Male Incontinence: Results of a Prospective 2-Center Study