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. 2017 Jul 26;2017(7):CD008709. doi: 10.1002/14651858.CD008709.pub3

Amat 2011 NDL.

Methods Quasi‐randomised prospective study comparing Contasure Needleless (C‐NDL) versus TVT‐O in a non‐inferiority design
Participants 158 women with SUI with or without associated prolapse
Interventions TVT‐O (60) (21 had SUI surgery alone)
Contasure Needleless (C‐NDL) (72) (34 had SUI surgery alone)
Outcomes Objective cure (stress test); subjective cure (Sandvik severity test, clinical history); Q‐tip test, ICIQ‐SF, urodynamics, complications, blood loss, postoperative pain
Notes Cure defined as negative stress test postoperatively, or score 0 on Sandvik questionnaire. Surgical procedure for stress incontinence only (with no prolapse surgery) done on 55 participants (34 in C‐NDL and 21 in TVT‐O)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "patients were assigned to one or other group of treatment depending on the last figure of their medical history number; last even figure was allocated for technical TVT‐O and last odd figure for C‐NDL"
Comment: inadequate randomisation method
Allocation concealment (selection bias) Unclear risk Not described
Incomplete outcome data (attrition bias) 
 All outcomes High risk 26 participants did not complete follow‐up schedule but were excluded from analysis. Statistical analysis performed on 60 participants in the TVT‐O group and on 72 in the C‐NDL group; these numbers are reported as adequate for analysis as per power calculation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding of surgeon not possible because of difference in technique. Blinding of participants not described
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described