Lee 2008.
Methods | QRCT comparing the efficacy and safety of TVT‐O and TOT (TOT, Dow Medics, Korea) | |
Participants | 100 women Inclusion criteria: women with USI Exclusion criteria: predominant urge incontinence or POP Preoperative work‐up included a medical history, physical examination, urinalysis, urodynamic evaluation, and I‐QOL questionnaire |
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Interventions | Group A: TVT‐O (n = 50) Group B: TOT (n = 50) |
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Outcomes | Surgical outcomes were evaluated by the cough‐stress test and symptom questionnaire and scored as cured, improved, or failed. Participants were considered ‘cured’ of SUI if they had a negative cough‐stress test result and there were no reports of urine leakage during stress. Participants were considered ‘improved’ if they did not leak on the cough‐stress test but may have had occasional urine leakage during stress; this occasional leakage did not influence their daily activities or require further treatment. Participants who did not meet these criteria were considered to have ‘failed’ treatment | |
Notes | Surgical outcomes in the 2 groups were compared about 1 year after surgery. TOT, Dow Medics, Korea = woven monofilament polypropylene mesh |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | 100 women with SUI were alternately assigned |
Allocation concealment (selection bias) | High risk | Quasi‐randomised study with no mention of allocation concealment |
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 |