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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

February 21, 2011
January 8, 2014
January 2011
October 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01301599 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • Drug: combination therapy
    alpha blocker and 5-alpha-reductase inhibitor medication
  • Drug: alpha blocker monotherapy
    alpha blocker monotherapy group
  • Drug: 5 alpha reductase inhibitor monotherapy
    5 alpha reductase inhibitor monotherapy
  • Experimental: combination group
    combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication
    Intervention: Drug: combination therapy
  • Active Comparator: alpha blocker group
    alpha blocker monotherapy
    Intervention: Drug: alpha blocker monotherapy
  • Active Comparator: 5 ARI group
    5 alpha-reductase inhibitor group
    Intervention: Drug: 5 alpha reductase inhibitor monotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
315
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Male
45 Years and older
No
Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu
Korea, Republic of
 
NCT01301599
2009-09-024
Yes
KYU-SUNG LEE, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
Samsung Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP