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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods Single‐centre RCT for stage 2 POPQ prolapse
PC‐generated randomisation
2‐year follow‐up
No CONSORT statement
Blinding not stated
Authors state power of 85% need sample size of 20 in each arm
Participants 40 randomised in abstract, however 44 were randomised, 4 of whom failed to return postoperatively and were excluded
Inclusion criteria: stage 2 POPQ cystocele with no plans of pregnancy in 12 months
Exclusion criteria: contemplating pregnancy, women with paravaginal defects, needing continence surgery, prior colposuspension or vaginal surgery, immunocompromised, or diabetics
Interventions A (n = 23): anterior colporrhaphy AC 0 polyglactin (Vicryl) suture
B (n = 21): self styled armless soft polypropylene (Gynemesh) mesh without AC
Outcomes Assessed at 6 weeks, 3 months, then every 6 months to 2 years postop
Reports the following review outcomes:
  • Awareness of prolapse (subjective persistence of symptom vaginal bulge)

  • Recurrent prolapse at 1 to 3 years

  • Mesh erosion

  • Bladder injury (cystotomy)

  • Objective failure rate stage 2 POPQ at Aa, Ba, Ap, or Bp

  • Bladder function (de novo SUI)

  • Sexual function (de novo dyspareunia)

  • Quality of life: PQOL questionnaire; change scores

  • Hospital stay

  • Operating time

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated number tables
Allocation concealment (selection bias) Unclear risk Sealed envelopes to ensure allocation concealment; as not consecutive sealed, opaque envelopes unclear
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Not stated
Blinding of outcome assessment (detection bias) All outcomes Low risk Reviewers blinded except when mesh exposure occurred
Incomplete outcome data (attrition bias) All outcomes Low risk At 1‐year, group A 20/23, group B 20/21
Selective reporting (reporting bias) Low risk Reports main review outcomes
Other bias Unclear risk Funding not stated; authors no COI