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 |
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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 |
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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 |
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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):
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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 |