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. 2018 Aug 19;2018(8):CD013108. doi: 10.1002/14651858.CD013108

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
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)
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
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
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