Background: The aim of the study was to evaluate the efficacy of Tension Free Vaginal Tape (TVT) for the surgical treatment of stress urinary incontinence.
Methods: The design was an open multicenter study including six Italian hospitals. Between January 1998 and November 1999, 429 stress incontinent women were enrolled in the study. Before surgery subjects had been studied through their history, urine culture, physical examination, cotton swab test, cough provocation test and urodynamic evaluation including: uroflowmetry, water cystometry and urethral profilometry. Incontinence inconvenience has been quantified through a 10-grade visual analogue scale (VAS). Postoperatively patients were assessed after 6, 12 and 24 months.
Results: The mean age of the patients considered was 57 years (range 31-83) and 78 of them had undergone a previous operation for the treatment of stress urinary incontinence or genital prolapse. Out of the 429 patients, 371 were followed for a minimum of 6 months, 11 were lost to follow-up and 47 had been operated recently. After surgery 355 subjects (96%) were subjectively cured and no leakage of urine was observed in 97% of the patients during the postoperative cough provocation test.
Conclusions: This study carried out on a great number of patients demonstrates that TVT is a safe and effective procedure for the treatment of stress urinary incontinence.