Evidence map›Paper›PMID 36520097›Full record

Trial reportHealth technology assessment (Winchester, England)2022

Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT.

Mohamed Abdel-Fattah, David Cooper, Tracey Davidson, Mary Kilonzo, Dwayne Boyers, Kiron Bhal, Alison McDonald, Judith Wardle, James N'Dow, Graeme MacLennan and 1 more

Registry-linked trialOpen access · diamondAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06731985 (The FAST- Study), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06731985 recruitingnot on this mapstarted 2024, after this paper: background citation

The FAST- Study: The Follow-up After Shorter Tapes Study Effectiveness and Safety of Shorter Trans-obturator Tapes: A Prospective Observational Study From the Norwegian Female Incontinence Registry

TypeobservationalSponsorUniversity Hospital, AkershusRan2024 to 2026Enrolled750ConditionsStress Urinary Incontinence, Postsurgical Pain, Follow-Up Studies
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Effectiveness and Safety of Shorter Incontinence Slings.International urogynecology journal · 2025
    Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Mohamed Abdel-FattahAberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-8290-0613
David CooperHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-9361-4399
Tracey DavidsonHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-4263-3389
Mary KilonzoHealth Economics Research Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-3450-4536
Dwayne BoyersHealth Economics Research Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-9786-8118
Kiron BhalObstetrics and Gynaecology, University Hospital of Wales, Cardiff, UK.ORCID 0000-0002-3559-0034
Alison McDonaldAberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-0256-2889
Judith WardlePatient and public involvement lead, UK.ORCID 0000-0002-7318-6665
James N'DowAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.ORCID 0000-0001-5340-0081
Graeme MacLennanAberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK.ORCID 0000-0002-1039-5646
John NorrieEdinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-9823-9252
University of Aberdeen · GBUniversity Hospital of Wales · GBUniversity of Edinburgh · GB

Funding

Chief Scientist Office HERU1Chief Scientist Office HSRU1Department of Health
6 · The paper itself

Abstract

backgroundStress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings.

objectiveThe objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness.

designThis was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio).

settingThe trial was set in 21 UK hospitals.

participantsParticipants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure.

interventionsSingle-incision mini-slings, compared with standard mid-urethral slings.

main outcome measuresThe primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function.

resultsA total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; LIMITATIONS: Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness.

conclusionsSingle-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years' follow-up. FUTURE WORK: Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness.

trial registrationThis trial was registered as ISRCTN93264234.

fundingThis project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in

Indexed as

Suburethral SlingsUrinary IncontinenceUrinary Incontinence, StressCost-Benefit AnalysisFemaleHumansPainQuality of LifeCOST–BENEFIT ANALYSISGROIN PAINMIDURETHRAL SLINGSQUALITY OF LIFESIMSSINGLE-INCISION MINI SLINGSSMUSSTRESS URINARY INCONTINENCESURGICAL MESH

Identifiers

PMID36520097
PMCPMC9761550
OpenAlexW4311525000

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.