One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur

Hamer, Maria Andrada; Larsson, Per Göran; Teleman, Pia; Eten-Bergqvist, Christina; Persson, Jan

doi:10.1007/s00192-012-1840-x

Cited by 30 publications

(9 citation statements)

References 37 publications

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“…Outcomes in women randomized to RP MUS and SIMS procedures were compiled in a recent Cochrane systematic review and meta‐analysis, and a 2017 update revealed no additional comparisons . Five trials compared the bottom‐to‐top RP MUS with various SIMS . Women were more likely to remain incontinent after SIMS than after RP MUS (41% vs 26%; RR 2.08; 95%CI 1.04‐4.14) and SIMS were associated with a higher risk of de novo urgency (RR 2.39; 95%CI 1.25‐4.56).…”

Section: Retropubic (Rp) Approachmentioning

confidence: 99%

Surgery for urinary incontinence in women: Report from the 6th international consultation on incontinence

Gomelsky

Athanasiou

Choo

et al. 2018

Neurourology and Urodynamics

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Urinary incontinence is a prevalent condition worldwide and causes a tremendous impact on a woman's quality of life. While conservative and non‐surgical therapies are options for treatment, surgery for stress urinary incontinence (SUI) is common. Options include colposuspension, slings (pubovaginal and midurethral), and periurethral bulking. While evidence supports each of these options in the treatment of SUI, each is associated with various rates of success and unique adverse event profiles. Urgency urinary incontinence (UUI) is initially treated with behavioral modification and pharmacologic means, with surgery reserved for those with refractory symptoms or significant complications from medication use. At present, intravesical onabotulinumtoxinA injections, percutaneous tibial nerve stimulation, and sacral neurostimulation are all viable options for refractory UUI/overactive bladder. As with surgical interventions for SUI, each of these is, likewise, associated with unique outcomes and adverse event profiles. Herein, we summarize the findings and conclusions from the 6th International Consultation on Incontinence (ICI) regarding surgical treatment of urinary incontinence in women.

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Section: Retropubic (Rp) Approachmentioning

confidence: 99%

Surgery for urinary incontinence in women: Report from the 6th international consultation on incontinence

Gomelsky

Athanasiou

Choo

et al. 2018

Neurourology and Urodynamics

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“…One other published randomized trial compared TVT Secur (using the hammock (H) technique that places the tape in a position replicating an obturator tape) to TVT, recruiting 125 women, less than half of the planned 280 patients [ 19 , 20 ]. Recruitment was stopped early because of a significantly lower cure rate at 2 months, and concern about three severe adverse events in the TVT Secur group (a tape erosion into the urethra, a tape placed inside the bladder, and bleeding from the corona mortis) [ 19 ].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2014

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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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“…The higher complication rate of the TVT procedure made most surgeons wonder whether a new, ‘safer’ variant (TVT‐Secur™) can be preferred, over the older procedure. However, in a recent multicentre study comparing TVT and TVT‐Secur™, the latter was linked to a higher rate of serious complications, one of which was postoperative bleeding due to injury of the corona mortis …”

Section: Discussionmentioning

confidence: 99%

“…This operation has given way to new, minimally invasive procedures, such as the TVT sling (introduced in 1998), the TOT sling (2002) and, finally, the TVT‐Secur™ (2006). However, these new methods are not free of complications, but have been linked to corona mortis – and in general, vessel – injury …”

Section: Introductionmentioning

confidence: 99%

Corona mortis: Anatomical data and clinical considerations

Stavropoulou-Deli

Anagnostopoulou

2013

Aust NZ J Obst Gynaeco

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One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur

Abstract: One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

Cited by 30 publications

References 37 publications

Surgery for urinary incontinence in women: Report from the 6th international consultation on incontinence

Surgery for urinary incontinence in women: Report from the 6th international consultation on incontinence

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

Corona mortis: Anatomical data and clinical considerations

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