Sub-urethral tape treatment of female urinary incontinence--morbidity assessment of the trans-obturator route and a new tape (I-STOP): a multi-centre experiment involving 604 cases.
PURPOSE: To make an assessment of the morbidity related to using the trans-obturator route (TOT); findings after one year for the 140 first cases and preliminary results of short term morbidity after 604 implants. PATIENTS AND METHOD: This retrospective, multi-centre study involves the 604 first procedures with a 1-3 month follow-up. The mean patient age was 57 years. 92% of the patients underwent an isolated urinary incontinence cure and 8% had associated surgery. 47.3% of the cases had pure stress urinary incontinence and 52.7% had mixed incontinence. A 12-month minimum follow-up period was applied to the first 140 cases operated between September 2002 and January 2003. Patient assessment was made by a clinical examination in the first three months and their satisfaction rate expressed after 1 year. RESULTS: Operative complications were very few: 0.5% vesical perforations, 0.3% vaginal perforations, no urethral wounds, 0.8% 200-300 ml haemorrhages, two perineal haematomas (0.33%). The post-operative period was marked by: 1.5% transient retentions, 2.3% transient pain, 2.5% urinary infections, 1.3% transient dysuria. The 1-3 month follow-up of 572 patients shows a 5.2% rate of de novo symptoms. Patient assessment of 131 subjects after one year revealed an encouraging satisfaction rate of 85.5% with a 1.5% rate of de novo dysuria and urgency. To date there have been no serious or specific complications attributable to the surgical route adopted. The morbidity is not affected by associated surgery. CONCLUSION: The trans-obturator route combines low morbidity with a low rate of de novo symptoms on a large series. These results will have to be corroborated by further studies.