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Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial.
Obstet Gynecol. 2009 Dec; 114(6):1287-94.OG

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.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, University of Calgary, Calgary, Alberta, Canada. sue.ross@albertahealthservices.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19935032

Citation

Ross, Sue, et al. "Transobturator Tape Compared With Tension-free Vaginal Tape for Stress Incontinence: a Randomized Controlled Trial." Obstetrics and Gynecology, vol. 114, no. 6, 2009, pp. 1287-94.
Ross S, Robert M, Swaby C, et al. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2009;114(6):1287-94.
Ross, S., Robert, M., Swaby, C., Dederer, L., Lier, D., Tang, S., Brasher, P., Birch, C., Cenaiko, D., Mainprize, T., Murphy, M., Carlson, K., Baverstock, R., Jacobs, P., & Williamson, T. (2009). Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstetrics and Gynecology, 114(6), 1287-94. https://doi.org/10.1097/AOG.0b013e3181c2a151
Ross S, et al. Transobturator Tape Compared With Tension-free Vaginal Tape for Stress Incontinence: a Randomized Controlled Trial. Obstet Gynecol. 2009;114(6):1287-94. PubMed PMID: 19935032.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. AU - Ross,Sue, AU - Robert,Magali, AU - Swaby,Cheryl, AU - Dederer,Lorel, AU - Lier,Doug, AU - Tang,Selphee, AU - Brasher,Penny, AU - Birch,Colin, AU - Cenaiko,Dave, AU - Mainprize,Tom, AU - Murphy,Magnus, AU - Carlson,Kevin, AU - Baverstock,Richard, AU - Jacobs,Philip, AU - Williamson,Tyler, PY - 2009/11/26/entrez PY - 2009/11/26/pubmed PY - 2009/12/22/medline SP - 1287 EP - 94 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 114 IS - 6 N2 - 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. SN - 1873-233X UR - https://www.unboundmedicine.com/medline/citation/19935032/Transobturator_tape_compared_with_tension_free_vaginal_tape_for_stress_incontinence:_a_randomized_controlled_trial_ L2 - http://dx.doi.org/10.1097/AOG.0b013e3181c2a151 DB - PRIME DP - Unbound Medicine ER -