The tension-free transvaginal tape procedure in the treatment of female urinary stress incontinence: a French prospective multicentre study.

OBJECTIVE: To evaluate in a prospective multicentre study (five centres) the preliminary results regarding efficacy and morbidity of the new tension-free transvaginal tape (TVT) technique in the treatment of urinary stress incontinence (USI) in women. METHODS: From November 1996 to May 1999, 52 women of mean age 64 (range 37--91) years underwent the TVT procedure to treat isolated grade 2 or 3 USI (44 cases) or grade 1 or 2 USI associated with uterine or rectal prolapse surgery (8 cases). Twenty-nine patients (55.8%) presented recurrent USI (1--4 previous procedures). Clinical data showed urethrovesical junction hypermobility in 35 cases (67.3%), isolated intrinsic sphincter deficiency (ISD) in 17 cases (32.6%) and pelvic organ prolapse in 8 cases. Urodynamics confirmed ISD in 27 cases (51.9%) with a mean urethral closure pressure of 18.5 (range 7--25) cm H(2)O. All data were collected by surgeons on a questionnaire. RESULTS: The surgical procedure was performed under spinal cord anaesthesia in 82.7% of patients (local anaesthesia 11.5%) with a mean operation time of 30 (range 20--60) min for TVT implantation. Six bladder injuries (11.5%) were identified and the needle was repositioned. Mean hospital stay was 2.5 (range 1-7) days in the group who underwent TVT alone. Mean follow-up of continence was 15.2 (range 6--36) months: 83% of patients were dry and 17% were improved. Nine patients (17.3%) required self-catheterization for 2--10 days postoperatively. No recurrence of USI, defect healing or tape rejection were reported. CONCLUSION: TVT is a new technique for the surgical treatment of USI which is useful for recurrent cases. The advantages are simplicity, low morbidity, reproducibility and reduced operative time. These early results indicate the technique is effective in correcting incontinence and is locally well tolerated. But these are preliminary data and the long-term outcome on USI and the urethra is needed.