Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01301599
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, 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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Numeric change of IPS and Numeric change of IPSS total score [ Time Frame: from baseline to 12 months of treatment ]

Secondary Outcome Measures :
  1. Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS [ Time Frame: from baseline to 12 months of treatment ]
  2. Changes in urodynamic parameters : maximal flow rate and PVR [ Time Frame: from baseline to 12 months of treatment ]
  3. change in finding of TRUS [ Time Frame: from baseline to 12 months of treatment ]
  4. Numeric Change and percent change in PSA [ Time Frame: from baseline to 12 months of treatment ]
  5. safety evaluation : incidence and severity of adverse events [ Time Frame: 12 months of treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301599


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center

Layout table for additonal information
Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01301599    
Other Study ID Numbers: 2009-09-024
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
Benign Prostatic Hyperplasia
alpha blocker
5-alpha reductase inhibitor
combination therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Adrenergic alpha-Antagonists
5-alpha Reductase Inhibitors
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists