Withagen 2011

Methods	Multi‐centre RCT 13 centres; 22 surgeons Randomisation list computer generated for each centre. Allocation concealment not discussed and woman, surgeon, and assessor (surgeons) not blinded Surgeons underwent specific Prolift mesh training Full power calculation completed
Participants	Randomised: Gp A 99, Gp B 95 1‐year examination: A 84, B 83 Inclusion criteria: recurrent stage 2 or higher anterior or posterior wall prolapse, or both Exclusion criteria: pregnancy, future pregnancy, prior vaginal mesh repair, a compromised immune system or any other condition that would compromise healing, previous pelvic irradiation or cancer, blood coagulation disorders, renal failure, upper urinary tract obstruction, renal failure and upper urinary tract obstruction, or presence of large ovarian cysts or myomas
Interventions	Gp A: conventional surgery was performed at the discretion of the surgeon, although absorbable sutures were specified and hysterectomies permitted Gp B: standardised and structured in the tension‐free vaginal mesh: performed as described by Fatton (Fatton 2007), and no hysterectomies were performed or T incisions allowed
Outcomes	Assessed at 6 months and 1 year Reports the following review outcomes at 1 year: Repeat prolapse surgery Repeat surgery for prolapse, SUI, or mesh exposure Mesh exposure Bladder injury (perforation) Surgery for mesh exposure POPQ assessment of prolapse: pts Ba, Bp, C (reports median and range) Bladder function: de novo SUI Sexual function: de novo dyspareunia; PISQ‐12 (Milani 2011 reports mean and SD) Quality of life: PGI‐I questionnaire: rate of "much or very much better" (and other questionnaires) Duration of surgery (reports median and range)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	High risk	Allocation concealment not described. Unfortunately, preoperatively group A is significantly different than group B, as demonstrated by having greater degree prolapse at Ap, Bp, and GH in Table 10; having significantly higher number with ≥ stage 2 apical compartment prolapse in those in Table I undergoing prior apical surgery, (36% (16/45) in group A versus 18% (10/56) in group B (P = 0.04, odds ratio 2.54)); and finally prior sacral colpopexy was 3 times as frequent in group B. Only the final anomaly is acknowledged
Blinding of participants and personnel (performance bias) All outcomes	High risk	Non‐blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Non‐blinded reviewers; participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Gp A 84/99, Gp B 83/98
Selective reporting (reporting bias)	High risk	Primary outcome definition inconsistent
Other bias	High risk	Funded by university research fund; all authors reported financial support from Ethicon, which manufactures product being evaluated by non‐blinded reviewers

AC = anterior colporrhaphy AVWP = anterior vaginal wall prolapse BW = Baden‐Walker CI = confidence interval COI = conflict of interest CONSORT = Consolidated Standards of Reporting Trials CRADI = Colorectal‐Anal Distress Inventory 
Hb = haemoglobin
 ICS = International Continence Society ITT = intention to treat 
IVS = intravaginal slingplasty
 N/S = not specified
 PDS = absorbable polydioxanone surgical suture
 PFDI = Pelvic Floor Distress Inventory
 PFIQ = Pelvic Floor Impact Questionnaire PGI‐I = Patient Global Impression of Improvement
 PISQ = Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire POP = pelvic organ prolapse POPDI = Pelvic Organ Prolapse Distress Inventory POPIQ = Pelvic Organ Prolapse Impact Questionnaire 
POPQ = Pelvic Organ Prolapse Quantification (according to ICS) PQOL= Prolapse Quality of Life Questionnaire
 QOL = quality of life
 RCT = randomised controlled trial SD = standard deviation SSF = sacrospinous fixation
 SUI = stress urinary incontinence (symptom diagnosis)
 UDI = Urogenital Distress Inventory