| Methods |
Multisite study
Randomization: numbered or coded identical containers administered sequentially
Blinding: patients, providers |
| Participants |
Geographic region: France
Study setting: community
N = 168
Baseline IPSS: NR
Baseline prostate volume: NR
Mean age (range): 69 (NR) years
Race: White
Diagnostic criteria: Patients with "prostatism" or for whom surgery was not indicated (no mechanical or infectious complications). |
| Interventions |
Control: matching placebo
Treatment: Permixon® 160 mg twice daily
Study duration: 10 weeks
Lost to follow‐up: 13% |
| Outcomes |
Symptom score (# of daily mictions)
Dysuria (4‐point scale)
Bladder residual volume
Nocturia
Dropouts due to side effects: NR |
| Notes |
Exclusions: Symptoms for at least 6 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
unclear |
| Allocation concealment (selection bias) |
Low risk |
adequate |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
adequate |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
adequate |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
per protocol analysis |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
High risk |
number randomized to each arm was not described |
