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Single-Incision Slings (SIS) - a New Option for the Surgical Treatment of Female Stress Urinary Incontinence.

ABSTRACT: The new development of single-incision slings (SIS) for the treatment of female stress urinary incontinence offers comparable results with only minimal side effects and will find wide acceptance in modern incontinence surgery. This mini-sling is inserted over a single vaginal incision and fixed on both sides to the pelvic wall tissue with special anchors, without passing through the groin and avoiding a blind tape passage. Compared with the established sub-urethral tapes, there are comparable success rates with fewer complications. Randomised prospective studies are needed to evaluate whether, in the long run, the benefits of the single incision technique can be correlated with satisfying continence results.

SUBMITTER: Naumann G

PROVIDER: S-EPMC4168529 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Single-Incision Slings (SIS) - a New Option for the Surgical Treatment of Female Stress Urinary Incontinence.

Naumann G G Albrich S S Skala C C Laterza R R Kölbl H H

Geburtshilfe und Frauenheilkunde 20120201 2

The new development of single-incision slings (SIS) for the treatment of female stress urinary incontinence offers comparable results with only minimal side effects and will find wide acceptance in modern incontinence surgery. This mini-sling is inserted over a single vaginal incision and fixed on both sides to the pelvic wall tissue with special anchors, without passing through the groin and avoiding a blind tape passage. Compared with the established sub-urethral tapes, there are comparable su ...[more]

PMID: 25284829

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Project description:IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

Project description:BackgroundMidurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.MethodsWe performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points.ResultsA total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.ConclusionsThe 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Dataset Information

Single-Incision Slings (SIS) - a New Option for the Surgical Treatment of Female Stress Urinary Incontinence.

Publications

Single-Incision Slings (SIS) - a New Option for the Surgical Treatment of Female Stress Urinary Incontinence.

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