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

Wang 2011.

Methods RCT comparing TVT, TVT‐O and TVT‐Secur
Participants Total of 102 women included in this Chinese trial
Inclusion criteria: women with urodynamically proven SUI. If MUI, then SUI was the predominant symptom
Exclusion criteria: women with previous surgical procedures for SUI
Mean age (years; SD): Group A: 56.6 (9.6); Group B: 56.0 (9.1)
Mean BMI kg/m² (SD): Group A: 25.3 (2.0); Group B: 27.3 (1.9)
Interventions Group A: TVT (n = 32)
Group B: TVT‐O (n = 36)
Group C: TVT‐ Secur (data not included in this review)
Outcomes
  • Objective cure: negative cough stress test

  • Subjective cure: absence of SUI symptoms

  • Improvement: negative or a positive cough stress test and reduced SUI symptoms:

  • Mean length of surgery

  • Bladder perforation

  • Voiding dysfunction

  • Groin pain

  • De novo urgency or urgency incontinence

  • Vascular injury

Notes Power test calculation performed
Women with SUI were put on anticholinergic treatment prior to surgery
QoL assessment was performed using the ICI‐Q‐SF pre‐operatively; no data for post‐operative scores
Cystoscopy routinely performed in TVT. Cystoscopy only performed if bladder injury was suspected in the TVT‐O group
Follow‐up 1, 3, 6 and 12 months
All women completed the trial (no loss to follow‐up)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer generated randomisation"
Allocation concealment (selection bias) Low risk Quote: “allocation was concealed using opaque sealed envelopes”
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 Low risk All participants completed follow‐up. All outcomes reported