Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)
This study is currently recruiting participants.
Verified December 2011 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01301599
First received: February 21, 2011
Last updated: December 17, 2011
Last verified: December 2011
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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 |
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: | February 2012 |
| Estimated Primary Completion Date: | December 2011 (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:
- 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
Contacts and Locations
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: | December 17, 2011 |
| 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 Prostatic Diseases Genital Diseases, Male Pathologic Processes Adrenergic alpha-Antagonists 5-alpha Reductase Inhibitors |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013