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

Phase 4

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: alpha blocker monotherapy; Drug: 5 alpha reductase inhibitor monotherapy; Drug: combination therapy

• Registration Number: NCT01301599
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alpha blocker group	alpha blocker monotherapy	alpha blocker monotherapy
5 ARI group	5 alpha reductase inhibitor monotherapy	5 alpha-reductase inhibitor group
combination group	combination therapy	combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication

Primary Outcome Measures

Name	Time	Method
Numeric change of IPS and Numeric change of IPSS total score	from baseline to 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
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
safety evaluation : incidence and severity of adverse events	12 months of treatment
Numeric Change and percent change in PSA	from baseline to 12 months of treatment

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of