Richter 2010.
Methods | RCT: multi‐centre randomised equivalence trial conducted in the USA | |
Participants | 597 women Inclusion criteria: age >21 years; predominant SUI for >3 months (urgency UI allowed); positive urinary stress test; bladder volume >300 ml Exclusion criteria: not defined Baseline characteristics similar between groups Mean age (years; SD): Group A: 52.7 (10.5); Group B: 53.1 (11.5) Previous incontinence surgery: Group A: 38/297; Group B: 41/298 Previous prolapse surgery: Group A: 13/297; Group B: 10/298 Postmenopausal: Group A: 209/297; Group B: 206/298 BMI kg/m²: Group A: 30.6; Group B: 30 HRT: Group A: 81/297; Group B: 90/298 Concomitant pelvic surgery: Group A: 73/298; Group B: 78/299 |
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Interventions | Group A: retropubic sling (TVT; n = 298) Group B: transobturator tapes (TVT‐O, and TOT Monarc; n = 299) (Group C (?): TVT‐O (inside‐out) ‐ separate data not provided) (Group D (?): TOT (Monarch, outside‐in) ‐ separate data not provided) |
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Outcomes | Composite primary outcomes:
Secondary outcomes:
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Notes | TOMUS trial NCT00325039 Per protocol Lost to follow‐up: Group A: 18/298; Group B: 14/299 PISQ measures dyspareunia, coital incontinence and fear of coital incontinence |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Permuted block randomisation schedule with stratification by centre |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "patients who were lost to follow‐up were considered to have had treatment failure and when patients who were lost to follow‐up were excluded” |