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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
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%
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
Interventions A (n = 46): AC
B (n = 44): AC with bovine pericardium collagen matrix graft reinforcement
Outcomes Assessed at 6 months, 1 year, and 2 years
Reports the following review outcomes:
  • Awareness of prolapse: measure unclear

  • Repeat surgery for prolapse

  • Graft erosion/exposure ‐ no events

  • POPQ assessment of prolapse: point Ba, C (reports median and range, no SDs)

  • Sexual function: PISQ‐12 (no SDs reported); de novo dyspareunia at 1 year

  • Quality of life: UDI‐6 (no SDs reported)

  • Operating time ‐ reported as median and range

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