Rudnicki 2014.
| Methods | Trial design: multi‐centre, parallel‐group randomised controlled trial involving 6 centres in Denmark, Norway, Sweden, and Finland | |
| Participants | Number of participants randomised: 161 (transvaginal mesh 79, anterior colporrhaphy 82) Number of participants analysed: 154 (transvaginal mesh 76, colporrhaphy 78) Mean age (mean ± SD): transvaginal mesh = 64.9 ± 6.4, colporrhaphy = 64.7 ± 6.6 Inclusion criteria: ≥ 55 years, ≥ stage 2 anterior vaginal wall prolapse POPQ Exclusion criteria: previous major pelvic surgery, with the exception of a hysterectomy for reasons other than genital prolapse, previous vaginal surgery, or hysterectomy for POP; concomitant prolapse of the uterus, or an enterocoele of stage 1 or higher; previous incontinence sling surgery performed through the obturator membrane; current treatment with corticosteroids; history of genital or abdominal cancer Setting: hospitals in Sweden, Norway, Finland, and Denmark Timing: April 2008 to December 2010 |
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| Interventions | Intervention: four‐arm transobturator vaginal anterior mesh (Avaulta); the central section is coated with an absorbable hydrophilic film of porcine collagen. Vaginal pack for ≥ 6 hours (79 underwent surgery as assigned) Comparison: anterior colporrhaphy, fascia plicated using intermittent 2–0 absorbable sutures, excessive trimming of vagina (all 82 underwent surgery as assigned) Follow‐up at 3, 12, and 13 months |
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| Outcomes |
Primary outcome: recurrent anterior prolapse (POPQ stage > 1) Secondary outcomes: quality of life, symptoms, and complications (frequency of erosions, postoperative infections, and dyspareunia). Questionnaires: PFIQ‐7, PFDI‐20, PISQ‐12, UIQ‐7, CRAIQ‐7, POPIQ‐7, POPDI‐6, CRADI‐8, UDI‐6 |
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| Notes | Intention‐to‐treat analysis: yes Sample size calculation: yes, to detect a difference of 20% in recurrence rate (defined as ≥ stage 2 cystocoele at 12‐month follow‐up) between the 2 groups. Accordingly, 112 participants had to be randomised. In anticipation of a dropout rate of 15%, the number of participants was increased to 130. Trial registration: ClinicalTrials.gov (NCT00627549): http://clinicaltrials.gov/ct2/show/NCT00774215 Funding: no funding by industry. Funded by Region Sealand Health research fund Conflicts of interest: none declared |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated block design stratified by centre |
| Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss of FU for 3/79 in mesh group and 4/82 in anterior repair group. All accounted for |
| Selective reporting (reporting bias) | Low risk | Outcomes stated are reported on. |
| Other bias | Unclear risk | No significant differences in baseline demographics |