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

de Tayrac 2004.

Methods RCT comparing TVT with TOT
Participants 61 women
Inclusion criteria: USI
Exclusion criteria: predominant urge incontinence; urodynamic detrusor instability; or prolapse
Mean age (years; SD): Group A: 54.7 (11.9); Group B: 53.6 (12.5)
Mean BMI kg/m² (SD): Group A: 24 (3.2); Group B: 25.2 (4.3)
Postmenopausal status: Group A: 18/30; Group B: 16/31
Previous continence surgery: Group A: 4/30; Group B: 1/31
Previous prolapse surgery: Group A: 4/30; Group B: 1/31
ISD: Group A: 4/30; Group B: 3/31
Interventions Group: A: TOT (n = 30)
Group: B: TVT (n = 31)
Outcomes
  • Subjective cure

  • Objective cure (negative cough stress test)

  • Objective cure and improvement

  • Mean operating time

  • Mean length of hospital stay

  • Bladder perforation

  • Vaginal tape erosion

  • Urethral tape erosion

  • De novo urgency/UUI

  • Voiding dysfunction

  • Sexual dysfunction measured using mean VAS score. No significant difference between the 2 groups in terms of improvement of sexual function

Notes The full article was retracted at the request of authors because appropriate ethics committee approval was not received prior to starting study. Nevertheless, participants did give written consent to be included in the trial and consented for the procedures. No methodological flaws were identified: the review authors therefore decided to include the data
TOT: Uratape mentor‐porges
Cystoscopy performed following TVT procedure
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Women were randomised using numbered, opaque sealed envelopes containing computer‐generated random allocations in a ratio of 1:1 in balanced blocks of 10. Envelopes were opened in the operating room by a nurse just before starting the procedure
Allocation concealment (selection bias) Low risk Adequate
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information