Methods | Single‐centre RCT Randomisation and allocation concealment described Evaluated 1 year after AC as compared to small intestine submucosa graft Blinded reviewers Sample size of 60 women was required to achieve a significance level of 0.05 and a power of 80%. This was based on the assumptions of a 25% difference in cure rates between the groups with a 10% loss to follow‐up rate |
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Participants | Inclusion criteria: women with point Ba ≥ ‐1 Exclusion criteria: hypertension, prior radiation, pelvic sepsis, diabetes, and chronic illness Concomitant surgery allowed including vaginal hysterectomy if greater than stage 2 uterine prolapse |
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Interventions | Gp A (27) AC with interrupted 0 polyglactin (Vicryl) sutures GP B (29) non‐cross‐linked xenograft porcine small intestine submucosa 7 x 10 cm with dissection to suprapubic arch fixed with 0 prolene x3 each side |
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Outcomes | Assessed at 1 year Reports the following review outcomes at 1 year:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation list |
Allocation concealment (selection bias) | Low risk | Centrally controlled allocation concealment appropriate |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded reviewers and participant‐completed validated questionnaires |
Incomplete outcome data (attrition bias) All outcomes | High risk | 1 year: Gp A 20/27(74%); Gp B 22/29 (76%) |
Selective reporting (reporting bias) | Low risk | Reports main review outcomes |
Other bias | Low risk | No COI and no external funding |