de Tayrac 2004.
Methods | RCT comparing TVT with TOT | |
Participants | 61 women Inclusion criteria: USI Exclusion criteria: predominant urge incontinence; urodynamic detrusor instability; or prolapse Mean age (years; SD): Group A: 54.7 (11.9); Group B: 53.6 (12.5) Mean BMI kg/m² (SD): Group A: 24 (3.2); Group B: 25.2 (4.3) Postmenopausal status: Group A: 18/30; Group B: 16/31 Previous continence surgery: Group A: 4/30; Group B: 1/31 Previous prolapse surgery: Group A: 4/30; Group B: 1/31 ISD: Group A: 4/30; Group B: 3/31 |
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Interventions | Group: A: TOT (n = 30) Group: B: TVT (n = 31) |
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Outcomes |
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Notes | The full article was retracted at the request of authors because appropriate ethics committee approval was not received prior to starting study. Nevertheless, participants did give written consent to be included in the trial and consented for the procedures. No methodological flaws were identified: the review authors therefore decided to include the data TOT: Uratape mentor‐porges Cystoscopy performed following TVT procedure |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Women were randomised using numbered, opaque sealed envelopes containing computer‐generated random allocations in a ratio of 1:1 in balanced blocks of 10. Envelopes were opened in the operating room by a nurse just before starting the procedure |
Allocation concealment (selection bias) | Low risk | Adequate |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information |