Methods |
Multicentre (5 sites) RCT comparing laparoscopic with open colposuspension; power calculation; computer‐generated randomisation schedule, randomisation numbers in double‐sealed envelopes with project secretary; F/U 2/52, 6/52, 3/12 and 1 year |
Participants |
62 women Inclusion criteria: age 21‐75, objective diagnosis of GSI with urine loss with cough and absence of detrusor activity with stress loss of urine, anatomic defect of urethrovesical junction (Q‐tip deviation > 30º from the horizontal) Exclusion criteria: need for concomitant surgical procedures, previous retropubic urethropexy, needle suspension or suburethral sling, neurologic deficit associated with incontinence, type III stress incontinence, detrusor instability that has not been treated and improved, absolute contraindications to laparoscopy (uterine fibroids or pelvic masses > 16 weeks gestational size, conditions in which participant cannot tolerate anaesthesia, severe bleeding disorders, acute peritonitis of upper abdomen with severe distension), pathology present at the time of surgery that requires additional surgery (eg. unsuspected ovarian mass) |
Interventions |
Group 1 (n = 28): laparoscopic colposuspension Group 2 (n = 34): open colposuspension To ensure similarity of operative technique all co‐investigators met at a common location at beginning of study to observe surgery and participate in animal laboratory Intraperitoneal approach for laparoscopy 0‐Ethibond suture, 2 sutures each side of urethra; suprapubic catheter |
Outcomes |
Operating time, blood loss, hospital stay, complications, fever, time to resumption of voiding, objective surgical success, urodynamics, time to return to work and normal activity, subjective success |
Notes |
3 laparoscopic colposuspensions were converted to open colposuspensions due to severe intraabdominal adhesions |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |