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. 2016 Nov 30;2016(11):CD004014. doi: 10.1002/14651858.CD004014.pub6

Menefee 2011.

Methods Double‐blinded triple‐arm RCT
Randomisation, allocation concealment, NS power, 33 in each group, 80% power to detect 35% difference with 5% type 2 error
2‐Year review
Participants Inclusion: women ≥ 18 years of age with a POPQ point Ba ≥ 0
Exclusion: NS
Concomitant surgery: hysterectomy, colpopexy, posterior repair, continence at surgeon's discretion
Interventions 99 randomised
A (32): standard anterior colporrhaphy using midline plication with delayed absorbable suture
B (31): vaginal paravaginal repair using free‐hand formed porcine dermis graft (Pelvicol)
C (36): vaginal/paravaginal repair using free‐formed polypropylene mesh (M). All graft material was secured to the arcus tendineus fascia pelvis by a Capio device with permanent monofilament suture
Outcomes Assessed at 2 years
Reported the following review outcomes at 2 years
  1. Repeat surgery for prolapse

  2. Recurrence of prolapse (POPQ Ba stage 2 or greater)

  3. Bladder injury (no events)

  4. Mesh erosion

  5. Objective failure of anterior compartment

  6. Sexual function: de novo dyspareunia (data not used, as no denominator reported); PISQ‐12 (median and range)

  7. Quality of life: PFIQ (median and range)

  8. Operating time

  9. Blood transfusion (no events)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated sequence
Allocation concealment (selection bias) Low risk Opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Double‐blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Moderate attrition 1 year: AC 24/32 (75%) ‐ porcine 26/31 (84%), mesh 28/36 (77%)
Selective reporting (reporting bias) Low risk Significant outcome data
Other bias High risk Study authors reported COI with companies producing product evaluated; funding by Boston Scientific, whose product Capio was being evaluated