Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Dec;114(6):1287-1294.
doi: 10.1097/AOG.0b013e3181c2a151.

Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial

Sue Ross  1 , Magali Robert, Cheryl Swaby, Lorel Dederer, Doug Lier, Selphee Tang, Penny Brasher, Colin Birch, Dave Cenaiko, Tom Mainprize, Magnus Murphy, Kevin Carlson, Richard Baverstock, Philip Jacobs, Tyler Williamson
Affiliations
Randomized Controlled Trial

Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial

Sue Ross et al. Obstet Gynecol. 2009 Dec.

Abstract

Objective: To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively.

Method: Women with SUI were randomly allocated to either transobturator tape or TVT procedures and reviewed at 12 months after surgery. The primary outcome was objective evidence of "cure," evaluated by standardized pad test (cure defined as less than 1 g urine leaked). Other outcomes included complications, subjective cure, incontinence-related quality of life, return to usual sexual activity, and satisfaction with surgery. Primary analysis compared the proportion of patients in each group who were cured at 12-month follow-up.

Results: A total of 199 women participated (94 in the transobturator tape group, 105 in the TVT group). Sixty-eight women (81%) in the transobturator tape group were cured, compared with 67 (77%) in the TVT group (relative risk 1.05, 95% confidence interval 0.90-1.23, P=.577). On vaginal examination, the tape was palpable for 68 women (80%) in the transobturator tape group and for 24 (27%) in the TVT group (relative risk 0.22, 95% confidence interval 0.13-0.37, P<.001). More women in the transobturator tape group experienced groin pain during vaginal palpation (13 [15%] in the transobturator tape group and five [6%] in the TVT group, P=.044). Quality of life improved significantly from baseline in both groups (30-point improvement in IIQ-7 score for both groups).

Conclusion: At 12 months, the majority of women had minimal leakage and their quality of life had improved significantly, but differences were not observed between groups. The presence of palpable tape, particularly among the transobturator tape group, is concerning; longer follow-up is needed to determine whether this outcome leads to extrusion or resolves over time.

Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00234754.

Level of evidence: I.

PubMed Disclaimer

References

    1. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7:81–5.
    1. Ward KL, Hilton P, United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomized trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325:67.
    1. Valpas A, Kivela A, Penttinen J, Kauko M, Kujansuu E, Tomas E, et al. Tension-free vaginal tape and laparoscopic mesh colposuspension in the treatment of stress urinary incontinence: immediate outcome and complications—a randomized clinical trial. Acta Obstet Gynecol Scand 2003;82:665–71.
    1. Cody J, Wyness L, Wallace S, Glazener C, Kilonzo M, Stearns S, et al. Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape for treatment of urinary stress incontinence. Health Technol Assess 2003;7:iii, 1–189.
    1. Karram MM, Segal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol 2003;101:929–32.

Publication types

Associated data