Methods | RCT. Follow‐up at 2, 3, 12 and 24 months. Women allocated to 1/2 interventions by random tables. All women available at follow‐up | |
Participants | 20 women recruited, 10 in each arm of the study. Inclusion criteria: GSI (urodynamic diagnosis), vaginal narrowing, post surgical scar, unsuitable for colposuspension. Exclusion criteria: not stated. Groups comparable for age, parity and number of previous surgical incontinence procedures. Menopausal status not reported |
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Interventions | A (10): porcine dermis sling operation B (10): Stamey bladder‐neck (needle) suspension |
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Outcomes | Cure stated as objective (urodynamic diagnosis, pad test) at 3 months and subjective at 24 months of follow‐up. Failure rates at 3 months: A: 1/10, B: 2/10 Failure rates at 24 months: A: 1/10, B: 3/10 Differences not statistically significant at 3 and 24 months Post op. complications: A: 9/10, B: 2/10 (operative blood loss, pyrexia, infective complications, supra pubic catheter permanence). Hospital stay: A: 20 (12.9), B: 7 (0.3). Late complications not reported. Voiding problems at 3 months: A: 4/10, B:2/10. Detrusor instability: A: 2/10, B: 1/10. Urge incontinence: A: 5/10, B: 3/10. No difference in frequency of uninhibited detrusor contractions, residual volume and maximum voiding pressure. Peak flow significantly reduced for A, although > 15 mL/s |
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Notes | Pad test at 12 and 24 months stated but not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number chart |
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 |