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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods Single‐centre RCT comparing polypropylene mesh surgery with site‐specific surgery in the treatment of cystocele
CONSORT statement: yes
Power calculation: 45 in each arm
Type of randomisation: computer generated
Blinding strategy: no (assessment was performed by non‐blinded reviewers)
Allocation concealment: not specified
Definition of cure/failure: "Acceptable cure" defined as cystocele less than ‐1 cm (stage 1 POPQ)
Follow‐up: mean 12 months (range 8 to 16)
Prolapse assessment: POPQ
Participants Inclusion: primary cystocele
Exclusion: SUI, concomitant rectocele or enterocele or recurrent cystocele
Randomised: 90 (45 to each arm)
Analysed: 85
Lost to follow‐up: 5
Interventions A (42): site‐specific polyglactin 910 anterior repair
B (43): self styled 4‐armed polypropylene (Parietene, Sofradim, France) mesh, no anterior repair
Concomitant surgery not standardised, management of concomitant apical prolapse was not specified in either group
Outcomes Assessed at 6 weeks, 6 months, and annually
Reports the following review outcomes at mean follow‐up of 1 year (range 8 to 16 months):
  • Recurrent prolapse (stage 2 or more POPQ)

  • Mesh erosion

  • Surgery for mesh erosion

  • POPQ assessment of pts Ba, C, Bp, total vaginal length (P values only)

  • Bladder function: de novo SUI

  • Sexual function: de novo dyspareunia

  • Quality of life: PQOL end‐score

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 Unclear risk Not stated
Blinding of outcome assessment (detection bias) All outcomes High risk Non‐blinded reviewers; objective assessment was participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes Low risk Flow diagram: 1 year Gp A 42/45, Gp B 43/45
Selective reporting (reporting bias) Low risk Reports main review outcomes
Other bias Low risk No funding and no COI