Lucas 2005.
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group, multicentre study | |
Participants | 149 patients (75 tamsulosin, 74 placebo), mean age 69.4 years | |
Interventions | A (75): Tamsulosin 0.4mg once daily B (74): Placebo TWOC 'after up to 8 doses' |
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Outcomes | Number who had successful TWOC: A 34/75, B 18/74 | |
Notes | Qmax, PVR volume and spontaneously voided volume analysed but not separately (in groups of 'any two successful criteria') | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | '...randomized, double‐blind, placebo‐controlled, parallel‐group, multicentre study' |
Allocation concealment (selection bias) | Unclear risk | Not specified ('...randomly assigned to receive...') |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete 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 | Low risk | Double blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified |
Other bias | High risk | 'This study was sponsored by a grant from Yamanouchi Pharma Ltd.' |