Kumar 2013.
Methods | Prospective, randomised placebo‐controlled single centre study | |
Participants | 60 patients (30 silodosin, 30 placebo). Mean age (SD):
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Interventions | A (30): Silodosin 8 mg once daily for 3 days B (30): placebo |
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Outcomes | Number who had successful TWOC: A 23/30, B 11/30 Factors influencing TWOC failure Effects of silodosin on uroflowmetry and IPSS in patients who had successful TWOC |
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Notes | Study conducted in tertiary care regional referral centre in Northern India Successful TWOC:
Failed TWOC:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | ‘...centrally established computer‐assigned randomization list...’ |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
Selective reporting (reporting bias) | Unclear risk | All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Placebo administered was ‘similar to silodosin capsule in colour, weight, and shape’ Unclear if personnel were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified |
Other bias | Low risk | Study groups were comparable at baseline Power calculation was performed Ethical approval obtained Written informed consent obtained No withdrawals/loss to follow‐up |