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. 2014 Jun 10;2014(6):CD006744. doi: 10.1002/14651858.CD006744.pub3

Kumar 2013.

Methods Prospective, randomised placebo‐controlled single centre study
Participants 60 patients (30 silodosin, 30 placebo).
Mean age (SD):
  • Group A: 64.5 (9.3)

  • Group B: 65.8 (8.1)

Interventions A (30): Silodosin 8 mg once daily for 3 days
B (30): placebo
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
Notes Study conducted in tertiary care regional referral centre in Northern India
Successful TWOC:
  • ‘If the patient voided successfully, a postvoid bladder scan was performed to measure his residual urine volume.  If there was less than 150 mL postvoid residual volume after voiding at least 100 mL of urine, he was considered to have a successful TWOC.’


Failed TWOC:
  • ‘...if the patient re‐experienced painful AUR or if the PVR urine volume was >150 mL, he was re‐catheterised and considered to have a failed TWOC.’

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