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

Magali Robert¹  Lorel Dederer¹  Stephen Kaye³  Jose Goncalves⁴  Magnus Murphy¹  Jane Schulz²  Selphee Tang¹  Sue Ross⁵ 

[1] Department of Obstetrics and Gynecology, University of Calgary, Calgary, Alberta, Canada;Department of Obstetrics and Gynecology, University of Alberta, Edmonton, Alberta, Canada;Department of Obstetrics and Gynecology, Lions Gate Hospital, North Vancouver, British Columbia, Canada;Department of Obstetrics and Gynecology, Penticton Regional Hospital, Penticton, British Columbia, Canada;Cavarzan Chair of Mature Women’s Health Research and Innovation, Department of Obstetrics and Gynecology, Lois Hole Hospital, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada

关键词: Surgical treatment;    Stress urinary incontinence;    Single incision device;    Randomized controlled trial;    Effectiveness;   

Others  :  1091209
DOI  :  10.1186/1756-0500-7-941

 received in 2014-03-21, accepted in 2014-12-15,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Ross et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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