| Methods |
Multisite study
Randomization: noted but not described
Blinding: patients, providers |
| Participants |
Geographic region: Germany
Study setting: private out‐patient centers
N = 140
Baseline IPSS: Prostagutt® forte 20.0; tamsulosin 21.0
Baseline prostate volume: NR
Mean age (range): 65.0 (NR) years
Race: NR
Diagnostic criteria: maximum urinary flow rate ≤ 12 mL/s at a urinary volume ≥ 150 mL. |
| Interventions |
Control: tamsulosin 0.4 mg daily
Treatment: Prostagutt® forte (sabal fruit extract+urtica root extract) twice daily
Study duration: 60 weeks
Lost to follow‐up: n = 3 (a total of 121 completed the trial at week 60) |
| Outcomes |
IPSS total score
IPSS QoL
CEDQ (Cologne Erectile Dysfunction Questionnaire)
Peak urine flow
Mean urine flow
Mean urine volume
Duration of flow increase
Ultrasound residual volume |
| Notes |
Exclusions: Patients whose peak urinary volume changed by more than 3 mL/s during a 2‐week period; < 50 yrs old; IPSS < 13 and < 3 for the IPSS QoL; residual urinary volume < 150 mL; congested urinary tract passages; an indication of BPH surgery; urinary tract infection; prostate carcinoma; diabetes; neurogenic or bladder dysfunction; previous treatment with 5ARI; concomitant medication that could interfere with treatment efficacy. |
| 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 |
Low risk |
adequate |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
not mentioned |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
adequate |
| Selective reporting (reporting bias) |
Low risk |
adequate |
| Other bias |
Low risk |
adequate |
