United States experience with tension-free vaginal tape procedure for urinary stress incontinence: assessment of safety and tolerability.

PURPOSE: The tension-free vaginal tape (TVT) procedure is an operation for treatment of stress urinary incontinence. A polypropylene mesh tape is placed to support the midurethra through a small vaginal incision. In this study, we present our preliminary results evaluating the safety, tolerability, and perioperative morbidity of this procedure.

MATERIALS AND METHODS: One hundred patients with stress urinary incontinence underwent the TVT procedure as part of an observational study. Patients were evaluated prospectively with history and pelvic examination, urodynamic studies, perioperative protocol, outcome and satisfaction questionnaire, and postoperative visits at 3 weeks and 2 months.

RESULTS: The procedure was performed with the patient under local anesthesia, using intravenous sedation in 97 patients and regional anesthesia in 3. Mean surgical time was 35.5 minutes. Bladder penetration occurred in 24 patients. Forty-two required overnight urethral catheterization. Mean hospital stay was 0.18 days. By 24 hours after the procedure, 95% were able to void. At 3-week follow-up, 88% of patients were completely continent and 9% significantly improved.

CONCLUSIONS: The TVT procedure for stress urinary incontinence is a safe, minimally invasive operation with minimal perioperative morbidity. Considering these preliminary findings and long-term European data of 1 to 3 years' experience with continence rate averaging 85%, the TVT procedure may prove to be the operation of choice to treat stress urinary incontinence for many women.