But 2008.
Methods | RCT of TVT‐O versus TOT (Monarc) | |
Participants | 120 women with SUI (31) and MUI (89) Inclusion criteria: women with SUI, or MUI, with SUI as the predominant symptom Exclusion criteria: MUI with predominant UUI Performed under local anaesthesia Mean age years (SD): 52.6 (6.8) |
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Interventions | Group A: TVT‐O (n = 60) Group B: TOT (n = 60) |
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Outcomes |
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Notes | Follow‐up 3 months All women attended for follow‐up |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Before the beginning of the study, the computer‐generated list of 120 random numbers (from one to 120) was made for two groups (60 random numbers for each group, optimum allocation ratio 1)" |
Allocation concealment (selection bias) | Unclear risk | Quote: "the consecutive study numbers were given after admission, and based on this admission number, either inside‐out or outside‐in procedure was selected later in the OR according to a computer‐ generated list of random number" |
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 data/information accounted for at follow‐up |