Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: combination therapy
* Drug: alpha blocker monotherapy
* Drug: 5 alpha reductase inhibitor monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male aged 45 years old and above (with no upper limit of age) patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months IPSS ≤ 12 Ability and willingness to correctly complete the micturition diary and questionnaire 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: An anticholinergic or antidiuretic if started less than 3 months prior to screening Patients who had surgical treatment due to LUTS Patients with suspected neurogenic bladder disorder Patients with cancer of any type including cancer of the prostate or bladder Patients with urethral stricture or bladder neck contracture Patients with suspicious chronic prostatitis/chronic pelvic pain syndrome Acute bacterial prostatitis less than 6 months prior to screening Symptomatic acute urinary tract infection (UTI) less than 1 months prior to screening Patients who had underwent prostatic biopsy less than one month prior to screening Patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination group<br>combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication | Drug: combination therapy<br>* alpha blocker and 5-alpha-reductase inhibitor medication<br>|
| Active Comparator: alpha blocker group<br>alpha blocker monotherapy | Drug: alpha blocker monotherapy<br>* alpha blocker monotherapy group<br>|
| Active Comparator: 5 ARI group<br>5 alpha-reductase inhibitor group | Drug: 5 alpha reductase inhibitor monotherapy<br>* 5 alpha reductase inhibitor monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric change of IPS and Numeric change of IPSS total score |  | from baseline to 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, alpha blocker, 5-alpha reductase inhibitor, combination therapy