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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods RCT (computer‐generated random number tables. Sealed envelopes concealed assignment) comparing 3 surgical techniques 3 arms, 1 centre Length of follow‐up: A + B + C, 23.3 months
Participants 83 women Inclusion: all women undergoing cystocele repair Exclusion: continence surgery, i.e. colposuspension or sling 114 randomised 5 withdrawals 26 lost to follow‐up (A 2: B 15: C 9), leaving 83 in trial
Interventions Gp A (33): anterior repair: midline plication without tension 0 PDS Gp B (24): ultra‐lateral: dissection to pubic rami laterally, plication paravaginal with tension 0 PDS interrupted Gp C (26): anterior repair plus mesh: standard plication midline polyglactin (Vicryl) mesh overlay, Vicryl sutures
Number and level of surgeons unknown
Outcomes Assessed at 6 months, 1 year, and 2 years
Reports the following review outcomes at median follow‐up 23 months (range 4.5 to 44.4 months)
  • Awareness of prolapse (reports symptom severity on visual analogue scale but no comparative data)

  • Recurrent prolapse (grade 2 or more prolapse at pts Aa or Ba or worse than preoperative staging)

  • Death

  • Mesh erosion

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
Allocation concealment (selection bias) Low risk Adequate
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
Incomplete outcome data (attrition bias) All outcomes High risk 83/114 randomised women included in analysis (73%)
Selective reporting (reporting bias) Unclear risk Main review outcomes reported, but no comparative data for most outcomes
Other bias Unclear risk No statement about funding. Significant disparity between total numbers in Table 7 and actual numbers with prolapse reported