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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301599
• Other study ID #: 2009-09-024
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• combination therapy
alpha blocker and 5-alpha-reductase inhibitor medication
• alpha blocker monotherapy
alpha blocker monotherapy group
• 5 alpha reductase inhibitor monotherapy
5 alpha reductase inhibitor monotherapy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric change of IPS and Numeric change of IPSS total score		from baseline to 12 months of treatment
Secondary	Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS		from baseline to 12 months of treatment
Secondary	Changes in urodynamic parameters : maximal flow rate and PVR		from baseline to 12 months of treatment
Secondary	change in finding of TRUS		from baseline to 12 months of treatment
Secondary	Numeric Change and percent change in PSA		from baseline to 12 months of treatment
Secondary	safety evaluation : incidence and severity of adverse events		12 months of treatment