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Abstract
Introduction Single-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 analysis A pragmatic, multicentre, non-inferiority randomised controlled trial.
Primary outcome measure The 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 measures The 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 analysis The 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 dissemination The 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 number ISRCTN93264234. 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.
- stress urinary Incontinence
- TENSION-FREE VAGINAL TAPES
- Single Incision Slings
- Mid-urethral slings
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Footnotes
Contributors MAF conceived the idea and wrote the protocol; JN contributed to the study design and the statistical analysis; GML contributed to the study design, the sample size calculation and wrote the statistical analysis plan; MK designed and wrote the economic analysis plan; RPA contributed to the clinical aspects of the protocol; JN contributed to the study design and clinical aspects of the protocol; JW contributed the layman summary as the patient representative; KM contributed to the study design, flow/Gantt charts; TD and AMD contributed to the trial oversight and the protocol amendments.
Funding This is a UK Collaborative Study funded by the NIHR Evaluation, Health Technology Assessment (HTA) Programme — Funder Number 12/127/157.
Competing interests MAF has been a previous speaker and or trainer for Bard, Astellas, Pfizer, AMS and Coloplast. He received travel grants to attend medical conferences from various companies and previously performed a research-led project funded by a research grant from Coloplast, which was received and administered by the University of Aberdeen. MAF was the Chairman of Scottish Pelvic Floor Network, which received support from different pharmaceutical and devices companies. MAF and RPA have provided industry-sponsorship proctorship training sessions to a number of surgeons training in SIMS prior to the study. None of the coapplicants have any financial interest and shares or sit on the advisory board for any relevant device companies.
Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval North of Scotland Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.