Withagen 2011.

Methods	Multi‐centre randomised controlled trial 13 centres, 22 surgeons Randomisation list computer generated for each of 13 centres. Allocation concealment was not discussed, and participants, surgeon and assessor (surgeon) were not blinded. Surgeons underwent specific Prolift mesh training. Full‐power calculation was completed.
Participants	Randomised: GP A 99, Gp B 95 1‐Year examination: A 84, B 83 Inclusion criteria: recurrent stage 2 or higher anterior and/or posterior wall prolapse Exclusion criteria: pregnancy, future pregnancy, prior vaginal mesh repair, 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, 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) previously, and no hysterectomies performed nor T incisions allowed
Outcomes	Assessed at 6 months and at 1 year Reported 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: points Ba, Bp, C (reported median and range) Bladder function: de novo SUI Sexual function: de novo dyspareunia, PISQ‐12 (Milani 2011 reported mean and SD) Quality of life: PGI‐I questionnaire: rate of "much or very much better" (and other questionnaires) Duration of surgery: reported median and range Definition of success is unorthodox and different in Methods (≥ grade 2 prolapse in the treated site) and Results sections (≥ grade 2 POP in treated compartment or subsequent prolapse surgery). Furthermore, definition of treated compartment varies in each group. A includes all surgical sites; B excludes sites at which mesh was not utilised.
Notes	Study authors concluded that at 12 months, anatomical failure was less in Gp B (Prolift mesh) as compared with Gp A. These findings were overshadowed by the fact that the 2 groups were significantly different before intervention in terms of important findings. Lack of allocation concealment in the randomisation process, variability in and unorthodox definitions of success, non‐blinded surgeons reviewing their own surgery ‐ significant limitations of the manuscript
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 was not described. Preoperatively, group A was significantly different from the mesh group B, as demonstrated by a greater degree of prolapse at Ap, Bp and GH in Table 4, and a significantly greater number with ≥ stage 2 apical compartment prolapse among those in Table 1 undergoing prior apical surgery: 36% (16/45) in the non‐mesh group vs 18% (10/56) in the mesh group (P = 0.04, OR 2.54); finally, prior sacral colpopexy was 3 times as frequent in the mesh group.
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	Low risk	1 year ‐ AC 90/95, mesh 96/99
Selective reporting (reporting bias)	Low risk	Significant outcome data
Other bias	High risk	Funded university research: All authors reported financial support from Ethicon, the company manufacturing the 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

COPD = chronic obstructive pulmonary disease

DM = diabetes mellitus

GH = genital hiatus

ICS = International Continence Society

IVS = intravaginal slingplasty

MUCP = maximum urethral catheter pressure

MUS = Mid‐urethral sling

NS = Not stated

OAB = overactive bladder

OR = odds ratio

OT = Operating time

PC = personal computer

PDS = absorbable polydioxanone surgical suture (PDS)

PFDI = Pelvic Floor Distress Inventory

PFIQ = Pelvic Floor Impact Questionnaire

PGI‐I = Patient Global Impression of Improvement

PISQ = Prolapse and Incontinence Sexual Questionnaire

POP = pelvic organ prolapse

POPQ = Pelvic Organ Prolapse Quantification (according to ICS)

PQOL = Prolapse Quality of Life Questionnaire

RCT = randomised controlled trial

SD = standard deviation

SIS = Small intestine submucosa

SS = statistically significant

SSF = sacrospinous (ligament) fixation

SUI = stress urinary incontinence (symptom diagnosis)

TCR = tension‐free cystocele repair

TVT = tension‐free vaginal tape

UDI = Urogenital Distress Inventory

UI = urinary incontinence

USI = urinary stress incontinence

UTI = urinary tract infection

VAS = visual analogue scale