Trans-obturator Vaginal Tape (TOT®) for female stress incontinence:: One year follow-up in 120 patients

Objectives: The aim of this study was to evaluate the effectiveness of a new minimally invasive surgical procedure, the Trans-obturator Vaginal Tape (TOTO) in the treatment of fernale urodynamic stress incontinence (USI) and to analyse functional results and quality of life after one year of follow up. Material and method: 120 consecutive women with stress urinary incontinence underwent the procedure since February 2002 under general or loco-regional anesthesia. Minimum follow up was one year (range 12-30 months). Mean age was 58 years (range 31-86). 70% of the patients had pure USI. 5 Patients were previously operated for USI. In 10 cases, concomitant repair of pelvic floor defects was mandatory. Collection of the data included operative time, pre- and post-operative complications. Patients were post-operatively assessed at one week, one month and one year. A validated urinary incontinence-specific measure of Quality of Life (QoL) questionnaire (Contilife (R)) was sent and completed 12 months after surgery. Results: The mean operative time was 12 min (range 6-30) with a catheterisation time of 0,9 day (range 0-2). No severe bleeding was observed. There were 13 minor lateral tears of the vagina without any sequelae. Three perforations of the urethra and one of the bladder occurred during the learning phase. In two cases a re-intervention was necessary for tape removal when the injury was not recognised during the procedure. Two transient urinary retention needed a supra pubic catheter and tape release. Eleven women presented transient voiding outflow obstruction. After one month, 93% patients were cured with no pad and a negative cough test with a full bladder. Uroflowmetry did not show any significant changes between pre- and post-operative time In all the population. De novo urgency occurred only in 2.5% and persistent dysuria (Q(max) < 10 ml/s and/or post-void residual volume > 120 cc) in 4%. 80% of patients were completely dry after one year and 12% were greatly improved. According to the pre-operative maximal urethral closure pressure, continence rate was 86% above 30 cm H2O and 76% below 30 cm H2O respectively. Global satisfaction of women at 1 year was 78% with good scores based on daily and effort activities. self-image, emotional and sexual activities. Conclusions: TOT (R) is a safe and effective new minimal invasive procedure for USI with a low rate of complications. To confirm the success of TOT (R), longer follow up in large population is mandatory to assess the reliability of this attractive technique. (c) 2005 Elsevier B.V. All rights reserved.