Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial.
OBJECTIVE
To compare the intraoperative and immediate postoperative performance of the retropubic tension-free vaginal tape (TVT) procedure with that of the transobturator tension-free vaginal tape (TVT-O) procedure as primary treatment for female urinary stress incontinence.


METHODS
Randomized multicenter comparative trial including four university hospitals and three central hospitals in Finland. Assessment preoperatively and 2 months postoperatively included a cough stress test and the following condition-specific quality of life questionnaires: the Urinary Incontinence Severity Score (UISS), the Detrusor Instability Score, the Incontinence Impact Questionnaire-Short Form, the Urogenital Distress Inventory-Short Form, and a visual analog scale (VAS). Operation time, theater time, hospital stay, intraoperative and immediate postoperative complications were recorded.


RESULTS
Of the 273 originally randomized patients, 267 underwent the allocated operation, 136 in the TVT group and 131 in the TVT-O group. No significant differences in objective or subjective cure rates were detected. Patients in the TVT-O group had a significantly longer hospital stay, needed significantly more postoperative opiate analgesia and had significantly more complications than the patients in the TVT group. Patients in both groups had a significant postoperative improvement in quality of life, as indicated by the results of all the questionnaires used, with no difference between the groups.


CONCLUSIONS
The TVT and the TVT-O procedures perform equally in terms of objective and subjective cure. The statistically significant higher complication rate in the TVT-O group is not regarded as clinically significant.


BACKGROUND
(www.ClinicalTrials.gov), NCT00379314


METHODS
I.
Laurikainen
Eija
E
Department of Obstetrics and Gynecology, Turku University Central Hospital, Helsinki, Finland.
Valpas
Antti
A
Kivelä
Aarre
A
Kalliola
Tuomo
T
Rinne
Kirsi
K
Takala
Teuvo
T
Nilsson
Carl Gustaf
CG
D000328:Adult; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D007431:Intraoperative Complications; D008875:Middle Aged; D011126:Polypropylenes / Q000627:therapeutic use; D011183:Postoperative Complications; D011788:Quality of Life; D053825:Suburethral Slings / Q000009:adverse effects / Q000191:economics; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000379:methods*
D011126:Polypropylenes