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


METHODS
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).


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00234754.


METHODS
I.
Ross
Sue
S
From the Departments of Obstetrics and Gynaecology, Family Medicine, Community Health Sciences, and Department of Surgery (Urology), University of Calgary, Calgary, Alberta, Canada; the Institute of Health Economics, Edmonton, Alberta, Canada; the Department of Statistics, University of British Columbia, Vancouver, British Columbia, Canada; and the Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Robert
Magali
M
Swaby
Cheryl
C
Dederer
Lorel
L
Lier
Doug
D
Tang
Selphee
S
Brasher
Penny
P
Birch
Colin
C
Cenaiko
Dave
D
Mainprize
Tom
T
Murphy
Magnus
M
Carlson
Kevin
K
Baverstock
Richard
R
Jacobs
Philip
P
Williamson
Tyler
T
D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D053825:Suburethral Slings; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000009:adverse effects