Trial reportInternational urogynecology journal2013
Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial.
Trial report in International urogynecology journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023Pooled it
- Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial.BMC research notes · 2014Trial
- Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results.International urogynecology journal · 2014Trial
- A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence.International urogynecology journal · 2014Trial
- Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence.International urogynecology journal · 2014Trial
- Evaluation of the efficacy of mini-sling in the treatment of stress urinary incontinence through patient-reported outcomes and transperineal ultrasonography.Journal of the Turkish German Gynecological Association · 2025Article
- Instruments Used for the Assessment of SUI Severity in Urogynecologic Surgical Trials: A Scoping Review.International urogynecology journal · 2024Article
- Credé maneuver to adjust tape tension during trans-obturator tape mid-urethral sling in mixed urinary incontinence.International urogynecology journal · 2020Article
- Single-incision midurethral sling shows less pain and similar success rate in a short-term follow-up compared to the transobturator tape method in the treatment of stress urinary incontinence.Turkish journal of urology · 2020Article
- Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2017Article
- Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis.International neurourology journal · 2015Article
- Safety considerations for synthetic sling surgery.Nature reviews. Urology · 2015Review
- Mini-slings can cause complications.International urogynecology journal · 2015Article
- A cohort study comparing a single-incision sling with a retropubic midurethral sling.International urogynecology journal · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisWe tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI).
methodsThis was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King's Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p < 0.05).
resultsGroups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) -15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI -11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p < 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p < 0.001).
conclusionTVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.
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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.