| Methods | RCT comparing laparoscopic with open colposuspension, power calculation on non patient‐orientated outcomes only F/U: 6/52 and 6/12 | |
| Participants | 200 women with urodynamic evidence of USI and no history of retropubic surgery, participants and ward staff blinded to procedure performed until discharge | |
| Interventions | Group 1 (n = 104): open colposuspension Group 2 (n = 96): laparoscopic colposuspension Different surgical expertise levels, the 2 senior surgeons together performed 70 laparoscopic colposuspensions before starting the trial | |
| Outcomes | Duration of surgery, blood loss, visual assessment scores for post‐op pain, voiding difficulties, duration of hospital stay, urinary continence scores, symptom questionnaire, urodynamics, evaluation of urogenital prolapse, QoL assessment using SF 36, SUDI, SIIQ, return to normal activities, adverse outcomes | |
| Notes | Adverse events: group 1: 1 bladder perforation requiring blood transfusion, group 2: 1 laceration to obturator vein, 5 bladder perforations, 2 of which required conversion to open procedure | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |