Evidence map›Paper›PMID 35353961›Full record

Trial reportThe New England journal of medicine2022

Single-Incision Mini-Slings for Stress Urinary Incontinence in Women.

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

Open access · bronzeAbstract readComparative StudyRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
11.1field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
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  4. Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Mohamed Abdel-FattahFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
David CooperFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
Tracey DavidsonFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
Mary KilonzoFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
Md HossainFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
Dwayne BoyersFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
Kiron BhalFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
Judith WardleFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
James N'DowFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
Graeme MacLennanFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
John NorrieFrom the University of Aberdeen, Aberdeen (M.A.-F., D.C., T.D., M.K., M.H., D.B., J. N'Dow, G.M.), University Hospital of Wales, Cardiff (K.B.), Oxford (J.W.), and the University of Edinburgh, Edinburgh (J. Norrie) - all in the United Kingdom.
University of Aberdeen · GB

Funding

Chief Scientist Office HERU1Chief Scientist Office HSRU1Health Technology Assessment Programme 12/127/157
6 · The paper itself

Abstract

backgroundUntil recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited.

methodsWe performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points.

resultsA total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, -1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group.

conclusionsSingle-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up. (Funded by the National Institute for Health Research.).

Indexed as

Prosthesis ImplantationSuburethral SlingsUrinary Incontinence, StressDyspareuniaFemaleHumansPatient Reported Outcome MeasuresPragmatic Clinical Trials as TopicQuality of LifeReoperationSurgical MeshTreatment OutcomeUnited Kingdom

Identifiers

PMID35353961
OpenAlexW4220745688

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.