| Methods |
Single‐site study
Randomization: noted but method not stated
Blinding: none |
| Participants |
Geographic region: Italy
Study setting: community
N = 60
Baseline IPSS: NR
Baseline prostate volume: NR
Mean age (range): NR (44 to 78) years
Race: White
Diagnostic criteria: Men with BPH without prior treatment; bladder residual volume of < 150 mL |
| Interventions |
Control: Depostat (gestonorone caproato 200 mg) intramuscularly every week for 8 weeks
Treatment: Permixon® 160 mg twice daily
Study duration: 8 weeks
Lost to follow‐up: none |
| Outcomes |
Dysuria (% of men with symptoms)
Pollachiuria
Nocturia
Peak urine flow
Voiding time
Prostate size
Dropouts due to side effects: none |
| Notes |
Exclusions: cancer; urogenital infections |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
unclear |
| 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 |
unlikely |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
