Methods | RCT. Details not given in abstract of trial. 3 treatment arms. 4 centres. Follow‐up 6 months and 1 year | |
Participants | 201 women randomised (mean age 52 years) to Pelvicol‐50, TVT‐72, autologous sling‐79. 85% were available for follow‐up at 1 year Inclusion criteria: women requiring primary surgical treatment for urodynamic SUI |
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Interventions | A (79) autologous sling B (50) Pelvicol C (72) TVT |
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Outcomes | Success and improvement rates were described Other outcome measures included: operative details, complications, dry/ improved rates, QoL assessment, catheterisation and re‐operation rates Median theatre time (min): A: 50, B: 35, C: 30 Median length post‐op stay (days): A: 4, B: 4, C: 2 Incontinent at 6 months: A: 41/79, B: 28/50, C: 35/72 Incontinent at 12 months : A: 41/79, B: 39/50, C: 32/72 Not improved at 6 months: A: 4/79, B: 13/50, C: 6/72 Not improved at 12 months: A: 8/79, B: 19/50, C: 5/72 Re‐operation rate: A: 0%, B: 0%, C: 0% Self‐catherterisation at 12 months: A: 1/79, B: 0/50, C: 0/72 |
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Notes | High re‐operation rates (1 in 5) in Pelvicol group so arm closed. Study closed at 6 years before target number reached. Interim analysis after the first 50 participants in each group No mention of how success rate was assessed in the abstract, on contacting a listed author, we were informed that the figures were patient‐reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to make judgement |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to make judgement |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Insufficient information to make judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data at 12 months. Study closed after 6 years due to failure to recruit target numbers and high reoperation rate |