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Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial.
Obstet Gynecol. 2008 Mar; 111(3):611-21.OG

Abstract

OBJECTIVE

To compare the safety and efficacy of the transobturator tape to tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence in patients with and without concurrent pelvic organ prolapse.

METHODS

One-hundred seventy women with urodynamic stress incontinence, including those with and those without pelvic organ prolapse, from three academic medical centers were randomized to receive TVT or transobturator tape. Subjects with detrusor overactivity or previous sling surgery were excluded. The primary outcome was the presence or absence of abnormal bladder function, a composite outcome defined as the presence of any the following: incontinence symptoms of any type, a positive cough stress test, or retreatment for stress incontinence or postoperative urinary retention assessed 1 year after surgery. This study is a noninferiority study design.

RESULTS

Of 180 women who enrolled in the study, 170 underwent surgery and 168 returned for follow-up, with a mean follow-up of 18.2+/-6 months. Mean operating time, length of stay, and postoperative pain scores were similar between the two groups. Bladder perforations occurred more frequently in the TVT group (7% compared with 0%, P=.02); otherwise, the incidence of perioperative complications was similar. Abnormal bladder function occurred in 46.6% of TVT patients and 42.7% of transobturator tape patients, with a mean absolute difference of 3.9% favoring transobturator tape (95% confidence interval -11.0% to 18.6%.). The P value for the one-sided noninferiority test was .006, indicating that transobturator tape was not inferior to TVT.

CONCLUSION

The transobturator tape is not inferior to TVT for the treatment of stress urinary incontinence and results in fewer bladder perforations.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475839.

Authors+Show Affiliations

Department of Obstetrics and Gynecology and Glickman Urological Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA. barberm2@ccf.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18310363

Citation

Barber, Matthew D., et al. "Transobturator Tape Compared With Tension-free Vaginal Tape for the Treatment of Stress Urinary Incontinence: a Randomized Controlled Trial." Obstetrics and Gynecology, vol. 111, no. 3, 2008, pp. 611-21.
Barber MD, Kleeman S, Karram MM, et al. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008;111(3):611-21.
Barber, M. D., Kleeman, S., Karram, M. M., Paraiso, M. F., Walters, M. D., Vasavada, S., & Ellerkmann, M. (2008). Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstetrics and Gynecology, 111(3), 611-21. https://doi.org/10.1097/AOG.0b013e318162f22e
Barber MD, et al. Transobturator Tape Compared With Tension-free Vaginal Tape for the Treatment of Stress Urinary Incontinence: a Randomized Controlled Trial. Obstet Gynecol. 2008;111(3):611-21. PubMed PMID: 18310363.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. AU - Barber,Matthew D, AU - Kleeman,Steven, AU - Karram,Mickey M, AU - Paraiso,Marie Fidela R, AU - Walters,Mark D, AU - Vasavada,Sandip, AU - Ellerkmann,Mark, PY - 2008/3/4/pubmed PY - 2008/4/25/medline PY - 2008/3/4/entrez SP - 611 EP - 21 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 111 IS - 3 N2 - OBJECTIVE: To compare the safety and efficacy of the transobturator tape to tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence in patients with and without concurrent pelvic organ prolapse. METHODS: One-hundred seventy women with urodynamic stress incontinence, including those with and those without pelvic organ prolapse, from three academic medical centers were randomized to receive TVT or transobturator tape. Subjects with detrusor overactivity or previous sling surgery were excluded. The primary outcome was the presence or absence of abnormal bladder function, a composite outcome defined as the presence of any the following: incontinence symptoms of any type, a positive cough stress test, or retreatment for stress incontinence or postoperative urinary retention assessed 1 year after surgery. This study is a noninferiority study design. RESULTS: Of 180 women who enrolled in the study, 170 underwent surgery and 168 returned for follow-up, with a mean follow-up of 18.2+/-6 months. Mean operating time, length of stay, and postoperative pain scores were similar between the two groups. Bladder perforations occurred more frequently in the TVT group (7% compared with 0%, P=.02); otherwise, the incidence of perioperative complications was similar. Abnormal bladder function occurred in 46.6% of TVT patients and 42.7% of transobturator tape patients, with a mean absolute difference of 3.9% favoring transobturator tape (95% confidence interval -11.0% to 18.6%.). The P value for the one-sided noninferiority test was .006, indicating that transobturator tape was not inferior to TVT. CONCLUSION: The transobturator tape is not inferior to TVT for the treatment of stress urinary incontinence and results in fewer bladder perforations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475839. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/18310363/Transobturator_tape_compared_with_tension_free_vaginal_tape_for_the_treatment_of_stress_urinary_incontinence:_a_randomized_controlled_trial_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=18310363.ui DB - PRIME DP - Unbound Medicine ER -