A randomized trial comparing TVT with TVT-O: 12-month results.
The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.
Rinne
Kirsi
K
Obstetrics and Gynecology, Kuopio University Hospital, P.O. Box 1777, Kuopio 70211, Finland. kirsi.rinne@kuh.fi
Laurikainen
Eija
E
Kivelä
Arre
A
Aukee
Pauliina
P
Takala
Teuvo
T
Valpas
Antti
A
Nilsson
Carl Gustaf
CG
D000328:Adult; D005260:Female; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods*; D011788:Quality of Life; D053825:Suburethral Slings / Q000009:adverse effects; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*