Methods | 3‐armed RCT comparing laparoscopic colposuspension using sutures, laparoscopic colposuspension using mesh with open colposuspension using sutures. power calculation, set in Sweden, 4 hospitals. Follow‐up 1 year. | |
Participants | 211 women randomised. All women referred with USI as their main symptom. Patient characteristics similar in each group | |
Interventions | Group 1 (n = 79): open colposuspension Group 2 (n = 53): laparoscopic colposuspension using sutures Group 3 (n = 79): laparoscopic colposuspension using mesh |
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Outcomes | Subjective cure and objective cure ( < 8 g/24 h on a 48‐h pad test, and leakage on a frequency/volume chart). VAS used to assess subjective improvement and QoL. Duration of surgery, blood loss, duration of catheter drainage, duration of hospital stay, complications (bladder perforation haematoma leading to re‐operation, UTI within 1 month, wound infection and urinary retention > 5 days) | |
Notes | Withdrawls before surgery: group 1 (n = 16); group 2 (n = 4); group 3 (n = 4) due to failure to meet all inclusion criteria or regret decision after randomisation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |