Meschia 2007.
| Methods | RCT of TVT versus TVT‐O | |
| Participants | Inclusion criteria: women with urodynamic SUI and urethral hypermobility Exclusion criteria: previous anti‐incontinence surgery; vaginal prolapse requiring treatment; coexisting pelvic pathology; known bleeding diathesis or current anticoagulant therapy; DO and urethral hypomobility (Q‐tip <20° from the horizontal with straining) |
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| Interventions | 206 women randomised, but 25 lost to follow‐up
Group A: TVT (n = 114) Group B: TVT‐O (n = 117) |
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| Outcomes | Primary outcome: success rate Secondary outcome: complication rate Outcome of surgical treatment was estimated both subjectively and objectively. Objective cure was defined as no leakage of urine whilst performing the cough provocation test. Subjective cure was defined as no urine loss during ‘stress’, and failure as any reported leakage of urine during exertion ICIQ‐SF, Women Irritative Prostate Symptoms Score (W‐IPSS), PGI‐S and PGI‐I questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL, and to measure the participant’s perception of incontinence severity and improvement |
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| Notes | Median follow‐up time was 6 months 6 women from Group A and 7 from Group B were lost to follow‐up without outcome data; reasons for loss to follow‐up not explored Cystoscopy was performed in all cases of TVT and 50% of cases of TVT‐O |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Women with SUI and urethral hypermobility were randomised to treatments according to a centralised computer‐generated random list. Researchers randomised participants by a telephone system to one of the treatment groups |
| Allocation concealment (selection bias) | Low risk | 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 | Low risk | No differential loss to follow‐up or differential attrition |