Trial reportBMC research notes2014
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.
Trial report in BMC research notes, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00685217 (Tension-free Vaginal Tape Management of Stress Incontinence in Women), which is not on this map. Cited by 4 papers, 1 of them a synthesis 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.
Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023Pooled it
- Instruments Used for the Assessment of SUI Severity in Urogynecologic Surgical Trials: A Scoping Review.International urogynecology journal · 2024Article
- Stress urinary incontinence in women: Current and emerging therapeutic options.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2017Review
- 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life.
resultsThe sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p=0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change -25 for both groups) but did not differ between groups (p=0.880).
conclusionOur small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research on new licensed devices in a rapidly changing surgical specialty, and further highlights the need for research before licensing if surgeons and their patients are to be confident in the effectiveness and safety of new surgical devices.
trial registrationClinicalTrials.gov NCT00685217, 22 May 2008.
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