Benign Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia, alpha blocker, 5-alpha reductase inhibitor, combination therapy
Brief summary
This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.
Interventions
DRUGcombination therapy
alpha blocker and 5-alpha-reductase inhibitor medication
DRUGalpha blocker monotherapy
alpha blocker monotherapy group
DRUG5 alpha reductase inhibitor monotherapy
5 alpha reductase inhibitor monotherapy
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male aged 45 years old and above (with no upper limit of age) 2. patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months 3. IPSS ≤ 12 4. Ability and willingness to correctly complete the micturition diary and questionnaire 5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Exclusion criteria
1. An anticholinergic or antidiuretic if started less than 3 months prior to screening 2. Patients who had surgical treatment due to LUTS 3. Patients with suspected neurogenic bladder disorder 4. Patients with cancer of any type including cancer of the prostate or bladder 5. Patients with urethral stricture or bladder neck contracture 6. Patients with suspicious chronic prostatitis/chronic pelvic pain syndrome 7. Acute bacterial prostatitis less than 6 months prior to screening 8. Symptomatic acute urinary tract infection (UTI) less than 1 months prior to screening 9. Patients who had underwent prostatic biopsy less than one month prior to screening 10. Patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric change of IPS and Numeric change of IPSS total score | from baseline to 12 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS | from baseline to 12 months of treatment |
| Changes in urodynamic parameters : maximal flow rate and PVR | from baseline to 12 months of treatment |
| change in finding of TRUS | from baseline to 12 months of treatment |
| Numeric Change and percent change in PSA | from baseline to 12 months of treatment |
| safety evaluation : incidence and severity of adverse events | 12 months of treatment |
Countries
South Korea
Outcome results
None listed