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

OBJECTIVE

Assessment of the 2 year outcome of the Minitape procedure.

DESIGN

A prospective observational study of women undergoing the Minitape 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 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.