Trial reportInternational urogynecology journal2011
Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.
Trial report in International urogynecology journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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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
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 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
- 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
- One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.International urogynecology journal · 2013Trial
- 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.International urogynecology journal · 2012Trial
- 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
- Fixation of the Ajust minisling based upon cadaveric study.International urogynecology journal · 2013Article
- Intraobserver and interobserver reliability of the three-dimensional ultrasound imaging of female urethral sphincter using a translabial technique.International urogynecology journal · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisThe aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.
methodsWe set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up.
resultsNo significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001).
conclusionsIn a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.
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Registered trials
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