Laparoscopic versus open colposuspension--results of a prospective randomised controlled trial.
OBJECTIVE: To compare the effectiveness and cost effectiveness of open and laparoscopic colposuspension in the treatment of stress urinary incontinence. DESIGN: A randomised controlled trial. Women were randomised between March 1999 and February 2002 and were seen for assessment at 6, 12 and 24 months, postoperatively. SETTING: Women were recruited from six gynaecology units in the UK. POPULATION: Women with proven stress urinary incontinence requiring surgery. METHODS: Open abdominal retropubic colposuspension or laparoscopic colposuspension. MAIN OUTCOME MEASURES: Primary outcomes were subjective (satisfaction with outcome) and objective (negative 1-hour pad test). Secondary outcomes were operative and postoperative morbidity and quality of life. The study was powered to demonstrate noninferiority, i.e. that the absolute cure rate of laparoscopic colposuspension was no more than 15% below that of open colposuspension. RESULTS: A total of 291 women were randomised, with 24-month data on subjective and objective outcomes in 88 and 82.5%, respectively. The intention-to-treat analysis indicated no significant difference in cure rates between open and laparoscopic surgery. The objective cure rates for open and laparoscopic were 70.1 and 79.7%, respectively. Subjective cure rates by satisfaction were lower than objective cure; 54.6 and 54.9%, respectively, and there was considerable nonconcordance both ways. CONCLUSIONS: Laparoscopic colposuspension is not inferior to open colposuspension in terms of curing stress urinary incontinence.