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) |
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Interventions | Group A: TVT (n = 32) Group B: TVT‐O (n = 36) Group C: TVT‐ Secur (data not included in this review) |
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Outcomes |
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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) |
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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 |