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. 2017 Jul 31;2017(7):CD006375. doi: 10.1002/14651858.CD006375.pub4

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
Interventions Group A: RPR (n = 33)
Group B: TOT (n = 90)
Outcomes Outcome results for TOT and RPR not reported as separate figures; we contacted the authors who supplied separate figures
  • Subjective cure: defined as self‐reported absence of SUI

  • Objective cure: defined as negative stress test (any leakage of urine was a defined as a failure)

  • Subjective cure3

  • Objective cure

  • De novo urgency incontinence

  • Voiding dysfunction

  • Tape release for POVD

  • Repeat incontinence surgery

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