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

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
Interventions Group A: retropubic (IVS‐02; n = 269)
Group B: transobturator (IVS‐04; n = 268)
Outcomes
  • Subjective cure

  • Subjective improvement

  • Mean operating time

  • Bladder perforation

  • Major vascular injury

  • De novo urgency/UI

  • Voiding dysfunction

  • Vaginal tape erosion

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
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