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

November 28, 2019 updated by: KYU-SUNG LEE, Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numeric change of IPS and Numeric change of IPSS total score
Time Frame: from baseline to 12 months of treatment
from baseline to 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS
Time Frame: from baseline to 12 months of treatment
from baseline to 12 months of treatment
Changes in urodynamic parameters : maximal flow rate and PVR
Time Frame: from baseline to 12 months of treatment
from baseline to 12 months of treatment
change in finding of TRUS
Time Frame: from baseline to 12 months of treatment
from baseline to 12 months of treatment
Numeric Change and percent change in PSA
Time Frame: from baseline to 12 months of treatment
from baseline to 12 months of treatment
safety evaluation : incidence and severity of adverse events
Time Frame: 12 months of treatment
12 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (ESTIMATE)

February 23, 2011

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-09-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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