Trial reportInternational urogynecology journal2012
Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up.
Trial report in International urogynecology journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses 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
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023Pooled it
- Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2017Pooled it
- What is the optimal length for single-incision tape?International urogynecology journal · 2019Trial
- Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial.International urogynecology journal · 2016Trial
- A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up.International urogynecology journal · 2016Trial
- Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling among women with stress urinary incontinence: 1-year follow-up study.International urogynecology journal · 2016Trial
- 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
- Instruments Used for the Assessment of SUI Severity in Urogynecologic Surgical Trials: A Scoping Review.International urogynecology journal · 2024Article
- Is the fixation of single incision TVT-S tape as good as that of transobturator tape? An ultrasound study of randomized trial results.International urogynecology journal · 2021Article
- Are the same tapes really the same? Ultrasound study of laser-cut and mechanically cut TVT-O post-operative behavior.International urogynecology journal · 2018Article
- TVT ABBREVO: cadaveric study of tape position in foramen obturatum and adductor region.International urogynecology journal · 2016Article
- 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
- A cohort study comparing a single-incision sling with a retropubic midurethral sling.International urogynecology journal · 2014Article
- A new surgery for recurrent or persist stress urinary incontinence in females after primary mid-urethral slings.International journal of clinical and experimental medicine · 2014Article
- Fixation of the Ajust minisling based upon cadaveric study.International urogynecology journal · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisThe aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI).
methodsThis single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire--Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked "Never"/"Urine does not leak" in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented.
resultsOne hundred ninety-seven women with proven SUI were randomized into three groups--TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02).
conclusionsOur study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.
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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.