Methods | Multi‐centre RCT 24‐month follow‐up Randomisation computer generated Allocation concealment without blinding of women or surgeon Not according CONSORT Sample size was calculated by estimating a recurrence rate of 35% with AC and 10% with graft reinforcement. Assuming a 2‐tailed hypothesis test with 5% type 1 error and 80% power, 80 women would be required. We enrolled 94 women assuming a drop‐out rate of 15% |
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Participants | Randomised: Gp A 47, Gp B 47 2 years: Gp A 33, Gp B 26 Examination: Gp A 27, Gp B 17 Inclusion criteria: point Ba ≥ ‐1 Exclusion criteria: total vaginal length < 6 cm, severe atrophy, isolated paravaginal defect, allergic to bovine material, prior vaginal implant surgery, or ulceration |
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Interventions | A (n = 46): AC B (n = 44): AC with bovine pericardium collagen matrix graft reinforcement |
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Outcomes | Assessed at 6 months, 1 year, and 2 years Reports the following review outcomes:
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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 | Opaque envelopes opened in theatre (not consecutive) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if assessors blinded, participant‐completed questionnaire |
Incomplete outcome data (attrition bias) All outcomes | High risk | Equal losses in both groups; only 50% completed 2‐year review |
Selective reporting (reporting bias) | Low risk | Reports main review outcomes |
Other bias | High risk | Extensive COI reported; study partly funded Synovis Life Technologies, whose bovine pericardium product was being evaluated |