| Methods | RCT. Abstract. Randomisation 2:1. 2 arms. Follow‐up 1 year | |
| Participants | 34 women randomised. No mention of baseline comparison Inclusion criteria: women 30‐77 years old with SUI due to hypermobility or ISD underwent surgical correction |
|
| Interventions | A (10): autologous fascia B (24): FortaPerm |
|
| Outcomes | Objective outcome assessment was urine loss using a provocative pad test Subjective participant evaluations included QoL questionnaire, incontinence diary, pain and global outcome assessments Biopsies were taken at 1 year from FortaPerm implant sites adjacent to urethra for histology Incontinent within 1st year: A: 1/10, B: 5/24 Not improved within 1st year (subjective): A: 0/10, B: 2/24 |
|
| Notes | FortaPerm is absorbable biomaterial composed of laminated sheets of purified porcine collagen matrix | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
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