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. 2017 Jul 26;2017(7):CD001754. doi: 10.1002/14651858.CD001754.pub4
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
Interventions A (10): porcine dermis sling operation
B (10): Stamey bladder‐neck (needle) suspension
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
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