Sivaslioglu 2008.
Methods | Trial design: multi‐centre RCT (2 sites) | |
Participants | Number of participants randomised: 90 Number of participants analysed: 85 Mean age: (mean ± SD): mesh group = 57.7 ± 9.4, site‐specific group = 50.1 ± 9.9 Inclusion criteria: primary cystocoele Exclusion criteria: stress urinary incontinence, concomitant rectocoele or enterocoele or recurrent cystocoele Setting: urogynaecology clinics of Ankara Etlik Maternity and Women’s Health Teaching Hospital Timing: January 2006 to January 2007 |
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Interventions | Intervention: self‐styled 4‐armed polypropylene (Parietene, Sofradim, France) mesh, no anterior repair (n = 43) Comparison: site‐specific Polyglactin 910 anterior repair (n = 42) Concomitant surgery not standardised, management of concomitant apical prolapse not specified in either group Follow‐up: mean 12 months (range 8 to 16) |
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Outcomes |
Primary outcome/s: objective failure (≥ stage 2 POPQ) Secondary outcome/s: PQoL score postop (mean ± SD), further prolapse surgery, SUI, dyspareunia de novo, mesh erosion |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: 45 in each arm required Trial registration: not stated Funding: not stated Conflicts of interest: not stated CONSORT statement: yes |
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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 performed objective assessment of patient‐completed questionnaires. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 90 women randomised and 5 lost to follow‐up balanced between groups |
Selective reporting (reporting bias) | Unclear risk | No further validated or structured reporting of secondary outcome findings apart from PQoL score |
Other bias | Low risk | No funding and no COI |