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

Samsung Medical Center

Status and phase: Completed; Phase 4

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: alpha blocker monotherapy; Drug: 5 alpha reductase inhibitor monotherapy; Drug: combination therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01301599

2009-09-024

Details and patient eligibility

About

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.

Enrollment: 308 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 3 patient groups

combination group

Experimental group

Description:

combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication

Treatment:

Drug: combination therapy

alpha blocker group

Active Comparator group

Description:

alpha blocker monotherapy

Treatment:

Drug: alpha blocker monotherapy

5 ARI group

Active Comparator group

Description:

5 alpha-reductase inhibitor group

Treatment:

Drug: 5 alpha reductase inhibitor monotherapy