Rechberger 2009.
Methods | RCT of retropubic IVS‐02 vs transobturator IVS‐04, multifilament type 3 tape | |
Participants | Inclusion criteria: women with SUI with a positive cough provocation test Exclusion criteria: presence of uterine myoma; ovarian cyst; or advanced uterine or vaginal prolapse (POP‐Q scale > grade 1) Mean age (years; SD): Group A: 55.56 (10.19); Group B: 55.75 (11.29) Postmenopausal: Group A: 119/269; Group B: 125/268 VLPP: leak pressure during Valsalva manoeuvre was measured. VLPP was determined at 180 ml of bladder filling. ISD was defined as VLPP of ≤ 60 cm H2O ISD: Group A: 45/269; Group B: 40/268 |
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Interventions | Group A: retropubic (IVS‐02; n = 269) Group B: transobturator (IVS‐04; n = 268) |
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Outcomes |
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Notes | The follow‐up visits were at 1, 4, 6, 12, and 18 months Cystoscopy only performed in the retropubic group Loss to follow‐up: Group A: 68/269; Group B: 71/268 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Simple randomisation was used from pseudorandom numbers generated by a computer to allocate patients into the IVS‐02 group or the IVS‐04 group” |
Allocation concealment (selection bias) | Unclear risk | Investigators Jankiewicz and Futyma were not involved in the surgical procedures, but they were responsible for the randomisation process |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "the surgeon was aware of the procedure being used” |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote:"Only investigators Jankiewicz and Futyma were involved in the follow‐up process, and they were blinded with regard to the treatment procedure used" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data accounted for and the equivalent no of women were lost to follow‐up in the 2 groups |