Laparoscopic versus open colposuspension—results of a prospective randomised controlled trial
Article first published online: 25 AUG 2006
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 113, Issue 9, pages 1007–1013, September 2006
How to Cite
Kitchener, H., Dunn, G., Lawton, V., Reid, F., Nelson, L. and Smith, A. (2006), Laparoscopic versus open colposuspension—results of a prospective randomised controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 113: 1007–1013. doi: 10.1111/j.1471-0528.2006.01035.x
- Issue published online: 25 AUG 2006
- Article first published online: 25 AUG 2006
- Accepted 15 June 2006.
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.