A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results.
OBJECTIVE
This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate.


METHODS
Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires.


RESULTS
At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups.


CONCLUSIONS
The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.
Palva
Kirsi
K
Department of Obstetrics and Gynecology, Helsinki University Central Hospital, POB 140 Haartmaninkatu 2, 00029, Helsinki, Finland.
Rinne
Kirsi
K
Aukee
Pauliina
P
Kivelä
Aarre
A
Laurikainen
Eija
E
Takala
Teuvo
T
Valpas
Antti
A
Nilsson
Carl Gustaf
CG
D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D011474:Prosthesis Design; D011788:Quality of Life; D012189:Retrospective Studies; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000601:surgery*; D014554:Urination