| Methods |
Single‐site study
Randomization: random allocation using tables of random numbers
Blinding: none |
| Participants |
Geographic region: Italy
Study setting: community
N = 30
Baseline IPSS: NR
Baseline prostate volume: NR
Mean age (range): 62.9 (55 to 76) years
Race: White |
| Interventions |
Control: SR 640 mg rectal capsule once daily
Treatment: SR 160 mg oral capsules 4 times daily
Study duration: 4 weeks
Lost to follow‐up: n = 0 |
| Outcomes |
Dysuria
Bladder residual volume
Prostate size
Pollachiuria
Overall effect of treatment summary
Dropouts due to side effects: none |
| Notes |
Exclusions: age < 50 and > 80; on current medication; prior treatment for BPH. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
adequate |
| Allocation concealment (selection bias) |
Unclear risk |
unclear |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
not blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
not blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
