Evaluation of tension-free vaginal tape procedure. Its safety and efficacy in the treatment of female stress urinary incontinence during the learning phase.

INTRODUCTION AND OBJECTIVES: The aim of this study was to evaluate preliminary results of tension-free vaginal tape (TVT), a new surgical procedure, performed during the learning phase for the treatment of stress urinary incontinence.

MATERIAL AND METHODS: One-hundred consecutive patients underwent surgery, between June 1998 and December 1999, by six different senior surgeons. Indications were socially annoying urinary stress incontinence which persisted after complete physical therapy education. Preoperative examination included a urodynamic evaluation program. Surgical procedure was performed according to Ulmsten technique under local, regional or general anaesthesia. Results were evaluated by self-evaluation questionnaire and the patients were followed for at least 1 year.

RESULTS: Perioperative complications were: 14 bladder injuries and one urethral perforation without sequelae (except prolonged bladder drainage up to 3 days). Postoperative complications were: 13 retentions including 3 persistent after 1 month. During the learning phase (50 first patients) bladder injuries, retention and dysuria were more frequent. Progressively, local anesthesia was abandoned while most of the 50 remaining patients had TVT performed under epidural anesthesia. Functional results were divided into 3 groups according to preoperative urethral closure pressure (UCP) and eventual concomitant prolapse repair (PR): (1) UCP >25 cm H2O no PR (59 patients): 39 were totally dry without any instability, 13 dry with de novo (4) or persistent (7) instability and 5 were moderately improved. (2) UCP <25 cm H2O no PR (25 patients): 11 were dry without instability, 5 dry with instability, 6 were improved and 4 failed. (3) PR (15 patients): 9 were dry, 4 were improved and 2 failed. For 2 patients a bladder erosion due to the tape occurred (7 and 11 months) after the TVT procedure.

CONCLUSIONS: During the learning phase, bladder perforation (22%) and retention (20%) were much more frequent than previously reported. Nevertheless, our results confirm that TVT appears to be an efficient procedure: 97% of patients were cured or improved when UCP >25 cm H2O, 85% when UCP <25 cm H2O and 87% when a PR was associated.