Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence.
OBJECTIVE
This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur (TVT-S) with the trans vaginal obturator tape (TVT-O) for the treatment of stress urinary incontinence.


METHODS
We set out to enroll 136 patients in our study. 106 patients with stress urinary incontinence were randomized to either the TVT-S (n = 56) or TVT-O (n = 50) procedure. Patients were evaluated postoperatively at 2 months and 1 year. Our primary outcome was objective cure measured by the cough test. Secondary outcomes of subjective symptoms, questionnaires, pain scores, complications, and urodynamic studies were also included. Statistical analysis was by Chi-squared, Kruskal-Wallis, Wilcoxon, and Fisher's exact tests as appropriate. P values of <0.05 were considered significant.


RESULTS
Objective cure rates were better for TVT-O compared with TVT-S at 1 year (86 % and 63 % respectively, p = 0.01). Subjective cure rates were 88 % for TVT-O and 63 % for TVT-S. Quality of life scores through questionnaires improved in both groups and were not statistically different. Initial post-operative groin pain was more prevalent in the TVT-O group; however, this resolved quickly with time.


CONCLUSIONS
TVT-O was superior to TVT-S in the objective cure of stress urinary incontinence at 1-year follow-up.
Department of Obstetrics and Gynecology, University of Manitoba, 203-430 River Avenue, Winnipeg, MB, Canada, R3L0C6.
Ken
K
Maslow
Chander
C
Gupta
Peter
P
Klippenstein
Lise
L
Girouard
D041342:Absorbent Pads / Q000706:statistics & numerical data; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D053825:Suburethral Slings / Q000009:adverse effects; D011795:Surveys and Questionnaires; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics