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Obstetrics & Gynecology 2007;109:4-11
© 2007 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Retropubic Compared With Transobturator Tape Placement in Treatment of Urinary Incontinence

A Randomized Controlled Trial

Eija Laurikainen, MD1, Antti Valpas, MD, PhD2, Aarre Kivelä, MD, PhD3, Tuomo Kalliola, MD4, Kirsi Rinne, MD5, Teuvo Takala, MD6 and Carl Gustaf Nilsson, MD, PhD7

From the 1Department of Obstetrics and Gynecology, Turku University Central Hospital, 2Central-Ostrobothnian Central Hospital, 3Oulu University Hospital, 4Central-Finland Central Hospital, 5Kuopio University Hospital, 6Päijät-Häme Central Hospital, and 7Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Helsinki, Finland.

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.

CONCLUSION: 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.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00379314

LEVEL OF EVIDENCE: I






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