Hiltunen 2007.

Methods	Trial design: multi‐centre randomised controlled trial (5 centres)
Participants	Number of participants randomised: 202 (POP repair with mesh 105, POP repair without mesh 97) Number of participants analysed: 200 (1 withdrawal from mesh group, 1 loss to follow‐up in no mesh group) Mean age (mean ± SD): mesh group = 66 ± 9, no mesh group = 65 ± 9 Inclusion criteria: postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond Exclusion criteria: apical defect indicating vaginal fixation or stress urinary incontinence necessitating surgery or main symptomatic prolapse component in the posterior vaginal wall. Also patients with gynaecological tumour or malignancy calling for laparotomy or laparoscopy and those with untreated vaginal infection Setting: 5 hospitals throughout Finland Timing: April 2003 to May 2005
Interventions	Intervention: anterior colporrhaphy (AC) + self‐tailored (from a 6 × 11‐cm mesh patch), 4 armed low‐weight polypropylene mesh (n = 104) Comparison: AC using a 0 or 2/0 multi‐filament suture (n = 96) Type of mesh: non‐absorbable monofilament polypropylene (Parietene light, Sofradim, France) Sutures for AC: absorbable 0 or 2/0 multi‐filament suture Concomitant surgery: vaginal hysterectomy, posterior repair, culdoplasty as required, no concomitant continence surgeries performed Follow‐up for 24 months
Outcomes	Primary outcome/s: recurrence of anterior vaginal wall prolapse reaching stage 2 by the POPQ system Secondary outcome/s: perioperative and postoperative complications, symptom resolution, post voidal urine residual volume Objective failure Symptomatic prolapse Awareness of bulge at 1 year Awareness of bulge at 2 years Further prolapse surgery Further continence surgery Operating time (minutes) Blood loss (mL) Stress incontinence de novo Mesh erosion Mesh exposure Further surgery for mesh exposure Sexual function
Notes	Two inconsistencies between 1‐year and 2‐year data. Reduction in mesh exposures from 17% at 1 year to 8% at 2 years is difficult to explain. Furthermore, the percentage of patients having undergone previous prolapse surgery at 1 year was 27% in the AC group and 18% in the mesh group, and the 2‐year report quotes 20% and 14%, respectively. There is also a further discrepancy. At 1 year, de novo SUI was 9/96 as compared to 15/104, and at 3 years the reported rate was lower at 5/96 vs 7/104 rate. Even if some of these underwent continence surgery, they should still be recorded as having de novo stress urinary incontinence. CONSORT statement: yes Intention‐to‐treat analysis: No. 1 withdrawal from mesh group, 1 loss to follow‐up in no mesh group Sample size calculation: yes, 202 participants calculated to allow for 15% dropout and to provide 80% power to detect a 20% difference in primary outcomes between groups Trial registration: Clinicaltrials.gov NCT00420225 Funding: supported by a grant from the Medical Research Funds of the Central Hospital of South Ostrobothnia, Seinäjoki, and Tampere University Hospital, Tampere, Finland. Conflicts of interest: study authors had no potential conflicts of interest to disclose. 3‐year follow up published (Nieminen et al)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisations
Allocation concealment (selection bias)	Low risk	Opaque sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding as to the operative technique was not used.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessors were not blinded to group allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	202 randomised, 1 withdrawal, and 1 loss to follow‐up. 200 analysed
Selective reporting (reporting bias)	Low risk	All prespecified outcomes appear reported.
Other bias	Low risk	No significant differences in baseline demographics, prior hysterectomy, or prolapse surgeries between the 2 groups