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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01301599
First received: February 21, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: combination therapy
Drug: alpha blocker monotherapy
Drug: 5 alpha reductase inhibitor monotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Numeric change of IPS and Numeric change of IPSS total score [ Time Frame: from baseline to 12 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS [ Time Frame: from baseline to 12 months of treatment ] [ Designated as safety issue: No ]
  • Changes in urodynamic parameters : maximal flow rate and PVR [ Time Frame: from baseline to 12 months of treatment ] [ Designated as safety issue: No ]
  • change in finding of TRUS [ Time Frame: from baseline to 12 months of treatment ] [ Designated as safety issue: No ]
  • Numeric Change and percent change in PSA [ Time Frame: from baseline to 12 months of treatment ] [ Designated as safety issue: No ]
  • safety evaluation : incidence and severity of adverse events [ Time Frame: 12 months of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 315
Study Start Date: January 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: combination group
combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication
Drug: combination therapy
alpha blocker and 5-alpha-reductase inhibitor medication
Active Comparator: alpha blocker group
alpha blocker monotherapy
Drug: alpha blocker monotherapy
alpha blocker monotherapy group
Active Comparator: 5 ARI group
5 alpha-reductase inhibitor group
Drug: 5 alpha reductase inhibitor monotherapy
5 alpha reductase inhibitor monotherapy

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301599

Contacts
Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, Ph.D    82-2-3410-3554    ksleedr@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01301599     History of Changes
Other Study ID Numbers: 2009-09-024
Study First Received: February 21, 2011
Last Updated: January 8, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Benign Prostatic Hyperplasia
alpha blocker
5-alpha reductase inhibitor
combination therapy

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
5-alpha Reductase Inhibitors
Adrenergic alpha-Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014