Evidence map›Paper›PMID 24737301›Full record

Trial reportInternational urogynecology journal2014

A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence.

Stefano Palomba, Angela Falbo, Rosamaria Oppedisano, Marco Torella, Caterina Materazzo, Antonio Maiorana, Achille Tolino, Pasquale Mastrantonio, Giovanni Battista La Sala, Luigi Alio and 3 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International urogynecology journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00751088 (A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence), which is not on this map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT00751088 phase4completednot on this map

A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.

TypeinterventionalSponsorUniversity Magna GraeciaRan2008ConditionsUrinary IncontinenceArmsMiniArc positioning, TVT secur system positioning, Ajust positioning, Tension free vaginal ttape
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Review
  7. 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

13 authors at 6 institutions in 1 country.

Stefano PalombaObstetrics and Gynecology Unit, Department of Obstetrics, Gynecology and Pediatrics, Azienda Ospedaliera "Santa Maria Nuova" - Istituto di Ricovero e Cura a Carattere Scientifico of Reggio Emilia, Reggio Emilia, Italy, stefanopalomba@tin.it.
Angela Falbo
Rosamaria Oppedisano
Marco Torella
Caterina Materazzo
Antonio Maiorana
Achille Tolino
Pasquale Mastrantonio
Giovanni Battista La Sala
Luigi Alio
Nicola Colacurci
Fulvio Zullo
SIMS Italian Group
University of Campania "Luigi Vanvitelli" · ITMagna Graecia University · ITSanta Maria Nuova Hospital · ITUniversity of Modena and Reggio Emilia · ITUniversity of Molise · ITUniversity of Naples Federico II · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisStudies have observed a significant heterogeneity in efficacy data for single-incision minislings (SIMS) as surgical treatment for female urinary incontinence (UI). Our study aim was to test the hypothesis that different vaginal kits for SIMS have different long-term outcomes.

methodsOne hundred and twenty women with stress (SUI) or mixed (MUI) UI were enrolled in a multicenter randomized clinical trial (registration number NCT00751088) and treated with three different SIMS (Ajust, MiniArc, or TVT Secur System). Duration of follow-up was at least 24 months from surgery. The primary outcome was the subjective cure rate at 24 months from surgery; secondary outcomes were rates of total failure and reoperations for UI.

resultsAt study end, no difference was detected between groups in terms of total subjective cure rate [21 (52.5%) vs. 26 (65.0%) vs. 21 (52.5%), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.412] or in terms of total failure rate [24 (60.0%) vs. 22 (55.0 %) vs. 27 (67.5 %), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.432]. The proportion of patients who received a second surgery for UI was also not significantly different between groups [13 (32.5%) vs. 10 (25.0%) vs. 13 (32.5%), in Ajust, MiniArc, and TVT Secur System, respectively; P = 0.831].

conclusionThe long-term efficacy of SIMS does not differ between the vaginal kits examined.

Indexed as

Suburethral SlingsAgedEquipment DesignFemaleFollow-Up StudiesHumansMiddle AgedQuality of LifeSexual BehaviorTime FactorsTreatment OutcomeUrinary Incontinence, Stress

Identifiers

PMID24737301
OpenAlexW2026566217

What OpenQuestion 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 OpenQuestion graph.