Iglesia 2010

Methods	Multi‐centre RCT Double blinded Power calculation included Randomisation computer generated stratified for presence uterine prolapse, allocation concealment, CONSORT guidelines met, no ITT analysis
Participants	173 excluded variety reasons Gp A 33, Gp B 32 Lost to follow‐up: Gp A 0, Gp B 0 Prior to surgery all demographic details similar between the 2 groups, except Gp B had lower POPDI‐6 score than Gp A Inclusion criteria:  ≥ 21 yrs, grade 2 to 4 (POPQ) uterovaginal or vaginal prolapse who agreed to undergo vaginal surgery, available for 12 months' review, and can complete questionnaires Exclusion criteria: multiple medical contraindications, short vagina, uterus > 12 weeks size, desire future fertility, and postpartum
Interventions	Gp A: uterosacral colpopexy with polytetrafluoroethylene sutures or sacrospinous colpopexy (Gortex sutures) and hysterectomy performed if uterus present Gp B: if point C or D on POPQ was ≥ ‐3 apical suspension with total vaginal mesh (Prolift), and if C or D was < ‐3 anterior Prolift was utilised. No T incisions were performed, and hysterectomy performed if uterus present
Outcomes	Assessed at 1, 2, and 3 years Reports the following review outcomes (at 3 years unless otherwise stated): Awareness of prolapse (vaginal bulge) Repeat prolapse surgery Repeat surgery for SUI Repeat surgery for prolapse, SUI, or mesh exposure surgery Recurrent prolapse (POPQ > stage 1) Death Mesh exposure POPQ assessment of prolapse pts Ba, Bp, C at 1 year (states medians and range) Bladder injury (perforation) Rectal injury (no events) Surgery for mesh exposure Bladder function: de novo SUI Sexual function: de novo dyspareunia; PISQ (median and range) Quality of life: PFDI; PFIQ (median and range) Transfusion (in 3‐month data): 0 vs 1 Days in hospital (Mann‐Whitney P value only)
Notes	The ethics committee stopped the study prior to completion due to predetermined  stopping criteria of mesh erosion rate of > 15% being reached, with 65 of the desired sample size of 90 having undergone interventions
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list
Allocation concealment (selection bias)	Low risk	Consecutive, sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Double blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 years: Gp A 26/32, Gp B 25/33
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	Funded American Urogynecologic Society Foundation and MedStar research; authors reported no COI