| Methods |
Multisite study
Randomization: random number generator program
Blinding: patients, providers |
| Participants |
Geographic region: Europe
Study setting: NR
N = 257
Baseline IPSS: PRO 160/120 (Prostagutt® forte) 18.0; placebo 18.0
Baseline prostate volume: PRO 160/120 44.9 cc; placebo 46.4 cc
Mean age (range): PRO 160/120 68 (NR) (n = 127); placebo 67 (NR) (n = 126)
Diagnostic criteria: Peak urine flow (voiding volume): <15 mL/s; change in max urinary flow between screening and of run‐in period ? 3 mL/s; urinary output at baseline: > 100 mL; IPSS total score ≥ 14; IPSS QoL ≥ 4. |
| Interventions |
Control: matching placebo
Treatment: PRO 160/120 160 mg SR + 120 mg Urtica dioica twice daily
Study duration: 24 weeks
Lost to follow‐up: n = 7 |
| Outcomes |
IPSS total score
IPSS QoL
Peak urine flow |
| Notes |
Exclusions: age < 50; PSA >10 ng/mL; PC; large residual urine > 350 mL; concomitant medications affecting micturition (α‐blockers); previous surgery on pelvis, urinary tract, urethral stricture or pelvic radiation; symptomatic urinary tract infection; chronic bacterial prostatitis; serious health risks; diabetes; diabetic neuropathy; mental condition to restrict informed consent. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
adequate |
| 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 |
Unclear risk |
unclear |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
