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. 2016 Nov 30;2016(11):CD004014. doi: 10.1002/14651858.CD004014.pub6

Nguyen 2008.

Methods Single‐centre RCT on anterior vaginal prolapse
CONSORT statement: yes
Power calculation: 38 in each arm
Type of randomisation: computer generated
Blinding strategy: primary surgeon ‐ until the surgery day; patients, research nurse and medical assistant remained blinded
Allocation concealment: sealed opaque envelopes
Definition of cure
  1. Anterior wall POPQ at stage < 2, ‘Optimal support’ = Aa and Ba at stage 0, ‘Satisfactory’ = Aa and Ba at stage 1 and improved from preop staging


Follow‐up: 12 months (full publication) and 24 months (abstract only)
Prolapse assessment: POPQ
Participants Inclusion: 21 years old and older with POPQ stage 2 or greater anterior prolapse requiring surgical correction
Exclusion: pregnancy (present or contemplated), prior repair with graft, systemic infection, compromised immune system, uncontrolled diabetes mellitus, previous pelvic irradiation/cancer, polypropylene allergy, scheduled for concomitant Burch or pubovaginal sling
Randomised: 76
Withdrawal: 1
Lost to follow‐up: 1
Analysed: 76
Interventions A (38): anterior colporrhaphy (AC) with delayed absorbable (PDS) sutures
B (38): AC + polypropylene 4‐armed mesh kit repair (Perigee, American Medical Systems)
Concomitant surgery: vaginal hysterectomy, bilateral salpingo‐oophorectomy, uterosacral suspension, mid‐urethral tape, site‐specific rectocele repair, perineoplasty, Apogee mesh kit repair
Concomitant prolapse and suburethral tape surgeries were performed in both groups
Outcomes Assessed at 1 year
Reported the following review outcomes at 1 year
  1. Repeat prolapse surgery

  2. Recurrent prolapse (anterior prolapse stage 2 or greater)

  3. Death (no events)

  4. Mesh exposure

  5. Objective failure of anterior compartment

  6. POPQ assessment of prolapse: points Ba, C, Bp; vaginal length (reported median and range)

  7. Sexual function: de novo dyspareunia; PISQ

  8. Quality of life: PFIQ (and other measures) ‐ end scores

  9. Operating time (median and range)

  10. Blood transfusion

  11. Days in hospital (median and range)

Notes Data regarding study methods were obtained from the full published article, with follow‐up at 12 months
PFDI ‐ Pelvic Floor Distress Inventory (quality of life measure)
PFIQ ‐ Pelvic Floor Incontinence Questionnaire (quality of life measure)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Low risk Sealed opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessors blinded; participant‐completed questionnaires
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Data set complete: AC 37/38, mesh 37/38
Selective reporting (reporting bias) Low risk Significant outcome data
Other bias Unclear risk No statement