Methods | RCT. Follow‐up 12 months. No details of allocation method given. Not all women available in follow‐up | |
Participants | 46 women recruited, 23 in each arm of the study. 34 women available for follow‐up, reasons for loss to follow‐up not reported. Inclusion and exclusion criteria were well defined | |
Interventions | A (23): rectus fascia sling B (23): Burch colposuspension |
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Outcomes | Cure defined as dry, symptom‐free (subjective based on history and objective on ultrasonography) Failure rate: A:0/17, B: 1/17 Late complications (1‐year follow‐up): A: 1 instability; 3 suprapubic pain and 1 dyspareunia; B: 1 instability, 2 dyspareunia and 2 genital prolapse (enterocele) |
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Notes | Ultrasonography for measurement of bladder neck mobility was tested in both groups pre and post operatory and showed significant improvement but no significant differences between the groups | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | High risk | 12 women missing lost to follow‐up, reason not reported. No mention of whether loss had impact on final analysis |