Nieminen 2008

Methods	Multi‐centre RCT on anterior vaginal prolapse CONSORT statement: yes Power calculation: 101 in each arm Type of randomisation: computer generated Allocation concealment: opaque envelopes Blinding strategy: not specified, but lack of a non‐surgical blinded outcome reviewer Definition of cure: less than stage 2 prolapse at Aa or Ba Follow up: 24 months Prolapse assessment: POPQ
Participants	Inclusion: postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond Exclusion: apical defect indicating vaginal fixation or SUI necessitating surgery or the main symptomatic prolapse component was in the posterior vaginal wall. Also women with gynaecological tumour or malignancy calling for laparotomy or laparoscopy, and those with untreated vaginal infection Randomised: 202 Withdrawals: 1 Lost to follow‐up: 1 Analysed: 200 No significant differences in baseline demographics, prior hysterectomy, or prolapse surgeries between the 2 groups
Interventions	Gp A (96): AC using a 0 or 2/0 multifilament suture Gp B (104): AC + self tailored (from a 6 x 11 cm mesh patch) 4‐armed low‐weight polypropylene mesh Type of mesh: non‐absorbable monofilament polypropylene (Parietene light, Sofradim, France) Sutures for AC: absorbable 0 or 2/0 multifilament suture Concomitant surgery: vaginal hysterectomy, posterior repair, culdoplasty as required, no concomitant continence surgeries were performed
Outcomes	Assessed at 2 months, 1, 2, and 3 years Reports the following review outcomes at 3 years: Awareness of prolapse (bulge) Repeat prolapse surgery Repeat continence surgery Recurrent prolapse (any compartment stage 2 or more) Mesh exposure Bladder injury Repeat surgery for mesh exposure Objective failure of anterior compartment POPQ assessment of prolapse: pts Ba, C, vaginal length Bladder function: de novo SUI
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	3 years: 95/104 (92%) vs 85/96 (89%)
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	Some inconsistencies in data across publications at different follow‐up times