Methods | Single‐centre non‐inferiority RCT Computer‐generated random number list Allocation at inclusion with surgeon aware only in operating theatre Envelopes allocation Sample size: 35 in each group, 80% power to detect 5% significant change with 10% drop‐out ITT analysis Assessors blinded Women unblinded |
|
Participants | Any anterior POP point Ba ≥ +1 on POPQ Excluded malignant urogenital disease, prior radiation, acute genitourinary infection, connective tissue disorders, steroid treatments, insulin‐dependent diabetes |
|
Interventions | All procedures under spinal by 3 experienced surgeons 1. AC: plicate fascia purse string 0 polyglactin (Vicryl), vaginal trimming, transvaginal trocar‐guided polypropylene mesh (kits donated by Promedon) Nazca TC (Promedon, Córdoba, Argentina) I prepubic and 2 transobturator macroporous monofilament; vagina closed overlapping fashion 355 accessed, 79 randomised AC 39 completed, 1‐year review n = 39 2. Anterior mesh 40 randomised, 40 completed 1‐year review Concomitant surgery as required |
|
Outcomes | Assessed at 1 year Reports the following review outcomes:
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random sequence generation tables |
Allocation concealment (selection bias) | Unclear risk | Envelopes (opaque?, sealed?) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Non‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 79 randomised, and all completed 1‐year review |
Selective reporting (reporting bias) | Unclear risk | Did not clearly report any of the primary outcomes of this review |
Other bias | Low risk | Funded by Federal University of Sao Paulo, Brazil; Promedon contributed
product free of charge No author COI |