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. 2017 Jul 26;2017(7):CD001754. doi: 10.1002/14651858.CD001754.pub4
Methods RCT. Follow‐up at 6 and 30 months. Women allocated to 1/2 interventions by a computer‐generated random table in a 2:1 ratio. All women available at follow‐up
Participants 48 consecutive women. Inclusion and exclusion criteria not clearly stated, but some participants with mixed incontinence
Interventions A (32): rectus fascia sling
B (16): Gore‐Tex sling operation
Outcomes Cure defined as complete freedom from SUI (clinically accessed) or improved (persistence or recurrence of SUI, but in lesser intensity)
Failure rates at 6 months: A: 6/32, B: 2/16
Failure rates at 30 months: A:11/32, B: 2/16
Complications: B: 2 cases of erosion of sling and 3 other cases of recurrent UTI
Notes Pre‐operative characteristics reported but no comparisons between groups made; statistical analysis reported for urodynamic parameters pre and post operation. No other statistical comparison between groups reported. Some participants with mixed incontinence, but results not stratified by groups or type of incontinence
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer randomised numbers, assigning 2 successive numbers to the fascial group and following number to Gore‐Tex group
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