Nyyssonen 2014.
Methods | RCT of TVT (Gynecare) vs TOT ('outside‐in' Monarc) | |
Participants | 100 women Inclusion criteria: women with SUI or MUI with a predominant stress component, after failed conservative treatment Exclusion criteria: urge incontinence; previous mini invasive operation for SUI and the need for another concomitant surgical procedure SUI diagnosed with a positive cough test Urodynamic testing was only done in 5 patients (10%) Pure SUI: Group A: 38/50; Group B: 30/50 Preoperative characteristics similar between groups |
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Interventions | Group A: TOT (n = 50) Group B: TVT (n = 50) |
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Outcomes |
Follow‐up at 3, 14 and 46 months Cough stress test was performed. Subjective cure and patient satisfaction recorded with aid of UISS and Detrusor Instability Score questionnaires with a specific question about satisfaction |
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Notes | Cystoscopy only performed in the TVT group Number available for follow‐up assessments: 14 months: Group A: 43/50; Group B: 43/50 At 46 months: Group A: 46/50; Group B: 47/50 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "This prospective randomized study included ... 100 patients were randomized either to the TVT or to the TOT" |
Allocation concealment (selection bias) | Low risk | Quote: "randomization was performed with sealed and numbered envelopes" |
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 | Low risk | No evidence suggestive of attrition bias |