Conditions of the Urinary Tract and Sexual Organs, and Pregnancy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Chinese ethnicity; 2. Age 45-85 y; 3. Diagnosed to have watchful waiting BPH (Qmax 150 mL and IPSS score <= 19); 4. Not on any concurrent alternative medications for BPH; 5. Mentally capable to give informed written consent and willing to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Prefers to have conventional medical or surgical treatment for BPH; 2. Concurrent treatment for unstable chronic diseases including unstable angina, less than 3 months post-MI or frequent exacerbation of COPD (more than 3x in the last year); 3. Known to have prostate cancer (PSA > 4 or Biopsy is +ve) or kidney and/or liver failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement in the uroflowmetry with a change of Qmax > 2 mL/sec after 12 months treatment when compared to placebo; | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement in symptoms and quality of life measured in the scores of IPSS and SF-12; | — |
Countries
China