van Leijsen 2013.
Methods | RCT comparing RPR and TOT | |
Participants | Dutch multicentre diagnostic cohort study with an embedded RCT 587 women with SUI; 123 randomised to surgery Inclusion criteria: women with urodynamically‐proven SUI, or MUI with SUI as predominant symptom following failed conservative treatment Exclusion criteria: prior incontinence surgery; POP > stage 2 POP‐Q; post PVR of >150 ml (by USS or characterisation) MUI: Group A: 18/33; Group B: 61/90 |
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Interventions | Group A: RPR (n = 33) Group B: TOT (n = 90) |
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Outcomes | Outcome results for TOT and RPR not reported as separate figures; we contacted the authors who supplied separate figures
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Notes | QoL questionnaires: UDI | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A web‐based application was used for block randomisation and computer‐generated random number list prepared by a database designer" |
Allocation concealment (selection bias) | Low risk | Quote: "Patient data were entered into a password‐protected web‐ based database" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Participants and health professionals were not blinded to the allocated arm and the urodynamic results" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Data input of subjective outcome measurements was per‐formed by researchers who were blinded to the treat‐ment allocation" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information |