Rudnicki 2014

Methods	Multi‐centre (6) international RCT Nordic countries: Norway, Sweden, Denmark, and Finland: Block computer‐generated randomisation list Allocation concealment: opaque, sealed envelopes ITT analysis Sample size: 130 women allowed 80% power to detect 20% difference with an alpha error of 5% and a drop‐out rate of 15% Assessors: surgeons Women unblinded Surgeons trained to ensure uniform surgery performed
Participants	Inclusion criteria: ≳ 55 years, anterior wall prolapse stage 2 POPQ Aa or Ba ≳ ‐1 Exclusion criteria: previous major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse, previous vaginal surgery, or hysterectomy for POP; concomitant prolapse of the uterus or an enterocele of stage 1 or higher; previous incontinence sling surgery performed through the obturator membrane; current treatment with corticosteroids; or a history of genital or abdominal cancer All surgery covered intra‐operative antibiotics and pre‐ and post‐local oestrogens Concomitant surgery allowed posterior repair
Interventions	AC group: interrupted absorbable suture fascial plication, vaginal trimming and closure with running unlocked absorbable suture Mesh group: biosynthetic system monofilament polypropylene mesh with central portion coated in absorbable hydrophylic porcine collagen film Bard Avaulta Plus anterior 169 available randomisation with 161 randomised AC: 79 randomised, 1 year 76 Mesh: 82 randomised, 1 year 78
Outcomes	Assessed at 3 months, 1 year, and 3 years Reports the following review outcomes at 1 year: Awareness of prolapse (vaginal bulge) (only P value reported) Recurrent prolapse (POPQ stage 2 or more) Mesh exposure Bladder injury (perforation) Surgery for mesh exposure POPQ assessment of prolapse: pts Ba, C, Bp, total vaginal length Bladder function: de novo stress incontinence Sexual function: PISQ, de novo dyspareunia Quality of life: PFIQ; PFDI Operating time Blood transfusion Days in hospital (reports rates of over or under 12‐hour stay)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Blocked computer‐generated randomisation list for each of 4 countries
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unblinded (unable to blind)
Blinding of outcome assessment (detection bias) All outcomes	High risk	Surgeons evaluated
Incomplete outcome data (attrition bias) All outcomes	Low risk	1‐year evaluation/randomised AC 76/79, mesh 78/82
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Unclear risk	No COI