Dahlgren 2011

Methods	Multi‐centre (8) Swedish open RCT Computer‐generated block randomisation stratified for each centre Allocation concealment in opaque, sealed envelopes Sample size was based on the assumption that a 15% difference in objective cure rate after 3 years between the implant‐augmented repair and the traditional colporrhaphy with 90% power should be significant at a 5% level. It was estimated that 160 women, 80 in each arm of the study, including a drop‐out of 10%, were needed 3‐year review ITT and CONSORT guidelines reporting not stated
Participants	Inclusion: recurrent (prior surgery on the prolapsing site) POP in anterior or posterior compartment, or both No exclusion criteria 135 randomised Gp A native tissue repair 66, and 3 years 60/66 Gp B porcine dermis repair 65, and 3 years 65/68
Interventions	Standardised surgery with 2 meeting workshops prior to study Native tissue repair: midline fascial plication interrupted polydioxanone suture, vagina closed polyglactin absorbable suture Porcine: porcine dermal implant (Pelvicol, Bard Sweden) as inlay with no fascial plication: inlay anchored to vaginal wall and fascia 6‐8 polydioxanone sutures, vagina closed polyglactin suture Concomitant mid‐urethral sling, apical support, and levator plication performed as required
Outcomes	Assessed at 3 months and 3 years Reports the following review outcomes: Awareness of prolapse (awareness of vaginal lump) at 3 years (presented in graph) Objective failure posterior compartment (Pt Bp median and range reported) Bladder function (urinary incontinence presented in graph) Bowel function (faecal incontinence presented in graph) Dyspareunia (presented in graph) Days in hospital (mean and range)
Notes	Did not reach sample size as slow to recruit
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated blocked randomisation list stratified for each centre
Allocation concealment (selection bias)	Unclear risk	Sealed, opaque envelopes (not stated if consecutive or not)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Nil
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	Gp A 60/68 and Gp B 65/68 completed 3‐year review
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No COI; funded by local research institutes