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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods Single‐centre RCT
CONSORT: no
Randomisation: computer generated
Allocation concealment: N/S
Women, surgeons, and reviewers not blinded
12 months' follow‐up
Participants Inclusion criteria: women who were recommended vaginal surgery for anterior and posterior compartment with ≥ grade 2 prolapse
Exclusion criteria: only requiring anterior or posterior compartment surgery, apical prolapse beyond the hymen, or those requiring abdominal mesh surgery
Randomised: 139 (A 70, B 69); 10 women breached study protocol, and 11 more recruited. All were analysed
Lost to follow‐up: A 6, B 9
Analysed 12 months:  A 63, B 61
Interventions A (70): traditional anterior and posterior fascial plication using polydioxanone sutures
B (69): anterior and posterior repair with Gynemesh PS augmentation
Outcomes Assessed at 6 months and 1 year postop
Reports the following review outcomes at 1 year:
  • Awareness of prolapse

  • Recurrent prolapse

  • Mesh erosion

  • Objective failure of anterior compartment

  • Sexual function: new dyspareunia

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) All outcomes High risk No blinding
Blinding of outcome assessment (detection bias) All outcomes High risk No blinding
Incomplete outcome data (attrition bias) All outcomes Low risk Native tissue 63/70; mesh 63/69 1 year
Selective reporting (reporting bias) Low risk Reports main review outcomes
Other bias High risk Funding not stated: authors' conflict of interest financial agreement with Ethicon manufacturer of product evaluated in study