Tension-free vaginal tape versus transobturator suburethral tape: five-year follow-up results of a prospective, randomised trial.
BACKGROUND
Many studies have assessed the equivalent effectiveness of tension-free vaginal tape (TVT) and transobturator suburethral tape (TVT-O) at short- to medium-term follow-up, but no long-term randomised trials appear in the literature.


OBJECTIVE
We compared the use of TVT to TVT-O, providing a longer follow-up than currently appears in the literature.


METHODS
Seventy-two consecutive patients affected by stress urinary incontinence (SUI) were included in this randomised, controlled trial. Patients were randomly allocated to the TVT or TVT-O procedure using a predetermined, computer-generated randomisation code.


METHODS
After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure.


METHODS
This 5-yr study represents the extension of our original randomised trial, which was designed to assess the incidence of long-term complications (primary end point) and successes (secondary end point) for both techniques.


CONCLUSIONS
At 60-mo follow-up, 52 patients (72%) were objectively cured of SUI (72.9% after TVT-O and 71.4% after TVT), but only 44 patients (61%) were satisfied. The late complication rate was 16.6% (10 women): five women (16.1%) in the TVT-O group and five women (17.2%) in the TVT group (p=1). In this follow-up, 62% of the patients from the TVT-O group and 60% from the TVT group (p=1) expressed that they were satisfied or very satisfied with the results. The mean cause of dissatisfaction was the development of sexual dysfunction resulting from dyspareunia or incontinence during intercourse, which was found in 6 of 16 dissatisfied patients (37.5%). The limitations of our study included the adequate but small sample size and the lack of questionnaires.


CONCLUSIONS
Both surgical techniques are safe, with similar results (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively) and low complication rates (16.6%: 16.1% and 17.2%, respectively, for TVT-0 and TVT), even after 5-yr follow-up.
Angioli
Roberto
R
Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Rome, Italy.
Plotti
Francesco
F
Muzii
Ludovico
L
Montera
Roberto
R
Panici
Pierluigi Benedetti
PB
Zullo
Marzio Angelo
MA
D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D010352:Patient Dropouts / Q000706:statistics & numerical data; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology*; D012008:Recurrence; D053825:Suburethral Slings / Q000009:adverse effects / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000453:epidemiology* / Q000601:surgery*