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

Lee 2007.

Methods RCT of TVT versus TVT‐O
Participants 120 women
Inclusion criteria: women with USI
Exclusion criteria: predominant urge incontinence or POP
Women had similar characteristics with regard to age, parity, incontinence symptoms and menopausal status
Interventions Group A: TVT (n = 60)
Group B: TVT‐O (n = 60)
Outcomes
  • Duration of operation

  • Intraoperative blood loss

  • Postoperative pain

  • Patient satisfaction

  • Operative complications

  • Cure: defined as no SUI symptoms and a negative cough‐stress test. Participants were considered to have improved if they had no leakage on the cough‐stress test but may have had occasional urine leakage during stress. However, this occasional leakage did not influence daily activities or require any further treatment. Participants who did not meet these criteria treatment were considered to have failed


Follow‐up was for 12 months
Notes Cystoscopy was performed only in the TVT group
Mean follow‐up 13 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "Patients were alternately assigned to the TVT or TVT‐O group" (Randomisation was by alternation method)
Allocation concealment (selection bias) High risk Not concealed
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information