| Methods |
Number of sites unknown
Randomization: unclear
Blinding: patients, providers |
| Participants |
Geographic region: France
Study setting: community
N = 110
Baseline IPSS: NR
Baseline prostate size: NR
Mean age (range): NR (NR) years
Race: White
Diagnostic criteria: peak urine flow; mean urine flow; residual urine volume (no details given) |
| Interventions |
Control: matching placebo
Treatment: Permixon® 80 mg twice daily
Average follow‐up: 4 weeks
Lost to follow‐up: 15% |
| Outcomes |
Dysuria
Mean urine flow
Bladder residual volume
Nocturia
Patient self‐rating
Physician self‐rating
Dropouts due to side effects: NR |
| Notes |
Exclusions: prostate cancer |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
not mentioned |
| Allocation concealment (selection bias) |
Unclear risk |
not mentioned |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
"double‐blind" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
not mentioned |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
per protocol analysis |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
