Park 2012.
Methods | Pseudo RCT of TVT‐O vs TOT (Monarc) | |
Participants | 74 women Inclusion criteria: women with SUI including those with MUI Exclusion criteria: neurogenic bladder; POP; suspected ISD; or a past history of radical pelvic surgery Mean age (years): Group A: 54.4 (10.13); Group B: 55.1 (10.63) Mean BMI kg/m²: Group A: 28.9 (0.53); Group B: 25.9 (0.48) Urgency/UUI: Group A: 25/39; Group B: 22/35 |
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Interventions | Group A: TVT‐O (n = 39) Group B: TOT Monarc (n = 35) |
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Outcomes | Cure was defined as the absence of any episodes of involuntary urine leakage during stressful activities and a stress test. Improvement was defined as a significant reduction in urine leakage, such that it did not require further treatment
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Notes | Cystoscopy was performed in all women | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “were included in this randomised, prospective, observational study” |
Allocation concealment (selection bias) | High risk | Quote: "The procedure was performed by a single surgeon, and patients underwent one of the two techniques in accordance with the scheduling order (MONARC and TVT‐O), in alternation" |
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 | All accounted for |