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) |
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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 |