A 2-year observational study to determine the efficacy of a novel single incision sling procedure (MinitapeTM) for female stress urinary incontinence

Objective Assessment of the 2 year outcome of the Minitape (TM) procedure. Design A prospective observational study of women undergoing the Minitape (TM) procedure for urodynamic stress incontinence. Setting Two tertiary referral urogynaecology units in the north of England. Population Sixty women between November 2002 and March 2006. Methods Women attended a research clinic where they completed a standardised 1 hour pad test and were examined. Women were assessed preoperatively and postoperatively at 6 months, 1 year and 2 years. Main outcome measures Success was determined by a negative 1 hour pad test (gain of < 1 g) and no desire for further treatment for stress urinary incontinence. Results All procedures were completed with local anaesthesia, with no additional sedation in 82% of cases. Intra-operative and immediate postoperative complications were rare. Twelve women (20%) experienced mesh complications, half of which were considered to be serious adverse events requiring exit from the study. At 2 years following Minitape (TM) insertion, six women (10%) were defined as cured. Conclusions Although feasible to perform, this procedure is associated with a substantially lower cure rate than that published previously for other procedures. Cure rates decline over the 2 year follow-up period, especially during the first 6 months.