De Tayrac 2013

Methods	Multi‐centre (12 French hospitals) RCT 12‐month review Randomisation by drawing lots, stratified by centre, allocation concealment not discussed Intention to treat stated yes, but women already randomised were removed if cystotomy occurred during surgery CONSORT guidelines Sample size of 194 provided 80% power to detect 20% difference with an alpha error 5% and drop‐out rate 10% Assessors not clear
Participants	Inclusion criteria: symptomatic stage 2 anterior wall prolapse, aged 60 years or older Exclusion criteria: steroids, poorly controlled diabetes, prior pelvic radiation, untreated vaginal or urinary infection, ascites, bladder injury during the procedure All used preoperative estrogen therapy 163 included, 162 randomised Gp A 82, 1 year 67/82 Gp B 80, 1 year 66/60 Preop demographics and potential confounders similar in both groups, except colorectal impact was greater group A
Interventions	Gp A: anterior colporrhaphy no mesh (plication of fascia with 2.0 polyglactin absorbable suture), uterosacral colpopexy and hysterectomy as required Gp B: anterior polypropylene macroporous mesh (Ugtex, Sofradim, Covidien) 4‐armed transobturator mesh fixed with 2 x 2.0 permanent polypropylene sutures to uterine isthmus or uterosacral ligaments and 2 x 2.0 polyglactin sutures to inferior edge of pubic rami; vaginal trimming minimised Concomitant surgery mid‐urethral sling, hysterectomy, and any native tissue repair, however no other transvaginal mesh intervention included
Outcomes	Assessed at 1‐year follow‐up Reports the following review outcomes: Awareness of prolapse ("functional recurrence") Repeat continence surgery Repeat surgery for prolapse, SUI, or mesh exposure Recurrent prolapse: stage 2 or more anterior prolapse Mesh exposure Repeat surgery for mesh exposure Objective failure of anterior compartment POPQ assessment of prolapse: point Ba POPQ assessment of prolapse: total vaginal length Bladder function: de novo SUI Bowel function: obstructed defecation Sexual function: de novo dyspareunia Operating time Blood transfusion Days in hospital
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation by drawing lots?
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	Gp A 82, 1 year 67/82 Gp B 80, 1 year 66/80 (20% attrition). 2 women who had bladder injury were excluded from analysis
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	High risk	Author COI with Sofradim, who provided partial funding and whose product was being evaluated. 2 women who had bladder injury were excluded from analysis; this outcome not reported clearly in both groups