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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
combination therapy
alpha blocker monotherapy
5 alpha reductase inhibitor monotherapy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, alpha blocker, 5-alpha reductase inhibitor, combination therapy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

combination group

alpha blocker group

5 ARI group

Arm Description

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

alpha blocker monotherapy

5 alpha-reductase inhibitor group

Outcomes

Primary Outcome Measures

Numeric change of IPS and Numeric change of IPSS total score

Secondary Outcome Measures

Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS
Changes in urodynamic parameters : maximal flow rate and PVR
change in finding of TRUS
Numeric Change and percent change in PSA
safety evaluation : incidence and severity of adverse events

Full Information

First Posted
February 21, 2011
Last Updated
November 28, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01301599
Brief Title
Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)
Official Title
Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, alpha blocker, 5-alpha reductase inhibitor, combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combination group
Arm Type
Experimental
Arm Description
combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication
Arm Title
alpha blocker group
Arm Type
Active Comparator
Arm Description
alpha blocker monotherapy
Arm Title
5 ARI group
Arm Type
Active Comparator
Arm Description
5 alpha-reductase inhibitor group
Intervention Type
Drug
Intervention Name(s)
combination therapy
Intervention Description
alpha blocker and 5-alpha-reductase inhibitor medication
Intervention Type
Drug
Intervention Name(s)
alpha blocker monotherapy
Intervention Description
alpha blocker monotherapy group
Intervention Type
Drug
Intervention Name(s)
5 alpha reductase inhibitor monotherapy
Intervention Description
5 alpha reductase inhibitor monotherapy
Primary Outcome Measure Information:
Title
Numeric change of IPS and Numeric change of IPSS total score
Time Frame
from baseline to 12 months of treatment
Secondary Outcome Measure Information:
Title
Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS
Time Frame
from baseline to 12 months of treatment
Title
Changes in urodynamic parameters : maximal flow rate and PVR
Time Frame
from baseline to 12 months of treatment
Title
change in finding of TRUS
Time Frame
from baseline to 12 months of treatment
Title
Numeric Change and percent change in PSA
Time Frame
from baseline to 12 months of treatment
Title
safety evaluation : incidence and severity of adverse events
Time Frame
12 months of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male aged 45 years old and above (with no upper limit of age) patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months IPSS ≤ 12 Ability and willingness to correctly complete the micturition diary and questionnaire 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: An anticholinergic or antidiuretic if started less than 3 months prior to screening Patients who had surgical treatment due to LUTS Patients with suspected neurogenic bladder disorder Patients with cancer of any type including cancer of the prostate or bladder Patients with urethral stricture or bladder neck contracture Patients with suspicious chronic prostatitis/chronic pelvic pain syndrome Acute bacterial prostatitis less than 6 months prior to screening Symptomatic acute urinary tract infection (UTI) less than 1 months prior to screening Patients who had underwent prostatic biopsy less than one month prior to screening Patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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