Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial.
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.


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


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475839.
Barber
Matthew D
MD
Department of Obstetrics and Gynecology and Glickman Urological Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA. barberm2@ccf.org
Kleeman
Steven
S
Karram
Mickey M
MM
Paraiso
Marie Fidela R
MF
Walters
Mark D
MD
Vasavada
Sandip
S
Ellerkmann
Mark
M
D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D013513:Obstetric Surgical Procedures / Q000379:methods; D053825:Suburethral Slings / Q000009:adverse effects; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*