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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combination group

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

Group Type EXPERIMENTAL

combination therapy

Intervention Type DRUG

alpha blocker and 5-alpha-reductase inhibitor medication

alpha blocker group

alpha blocker monotherapy

Group Type ACTIVE_COMPARATOR

alpha blocker monotherapy

Intervention Type DRUG

alpha blocker monotherapy group

5 ARI group

5 alpha-reductase inhibitor group

Group Type ACTIVE_COMPARATOR

5 alpha reductase inhibitor monotherapy

Intervention Type DRUG

5 alpha reductase inhibitor monotherapy

Interventions

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combination therapy

alpha blocker and 5-alpha-reductase inhibitor medication

Intervention Type DRUG

alpha blocker monotherapy

alpha blocker monotherapy group

Intervention Type DRUG

5 alpha reductase inhibitor monotherapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No