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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.

Ross S, Tang S, Schulz J, Murphy M, Goncalves J, Kaye S, Dederer L, Robert M - BMC Res Notes (2014)

Bottom Line: 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.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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, Alberta, Canada. sue.ross@albertahealthservices.ca.

ABSTRACT

Background: In 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.

Results: The 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).

Conclusion: Our 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 registration: ClinicalTrials.gov NCT00685217, 22 May 2008.

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Related in: MedlinePlus

Flow of patient recruitment and follow-up.
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Fig1: Flow of patient recruitment and follow-up.

Mentions: Figure 1 shows a flow diagram of patient recruitment and follow-up in the study. Four women consented to join the study but eventually chose not to have surgery and were not randomized. Seventy-four women were randomized into the study: academic centres recruited 26 and 27 subjects, the academic community hospital recruited 6 and the academic regional hospital recruited 16. Women had their surgery between February 2009 and March 2011. Forty women were randomly allocated to the TVT Secur Group and 34 to the TVT Group. A total of 68 (92%) were followed up at 12 months.Figure 1


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.

Ross S, Tang S, Schulz J, Murphy M, Goncalves J, Kaye S, Dederer L, Robert M - BMC Res Notes (2014)

Flow of patient recruitment and follow-up.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4307185&req=5

Fig1: Flow of patient recruitment and follow-up.
Mentions: Figure 1 shows a flow diagram of patient recruitment and follow-up in the study. Four women consented to join the study but eventually chose not to have surgery and were not randomized. Seventy-four women were randomized into the study: academic centres recruited 26 and 27 subjects, the academic community hospital recruited 6 and the academic regional hospital recruited 16. Women had their surgery between February 2009 and March 2011. Forty women were randomly allocated to the TVT Secur Group and 34 to the TVT Group. A total of 68 (92%) were followed up at 12 months.Figure 1

Bottom Line: 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.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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, University of Calgary, Calgary, Alberta, Canada. sue.ross@albertahealthservices.ca.

ABSTRACT

Background: In 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.

Results: The 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).

Conclusion: Our 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 registration: ClinicalTrials.gov NCT00685217, 22 May 2008.

Show MeSH
Related in: MedlinePlus