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The Effect of Daily Tamsulosin 0.2mg Administration on Renal Function in Patients With Benign Prostatic Hyperplasia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Seung-Ju Lee, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT02033798
First received: January 8, 2014
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine whether medical treatment for bladder outlet obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.


Condition Intervention
Chronic Kidney Failure
Prostatic Hyperplasia
Drug: Tamsulosin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Maximal flow rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This parameter can be obtained from urodynamic study.

  • Maximal detrusor pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This parameter can be obtained from urodynamic study.

  • Bladder outlet obstruction index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This parameter can be obtained from urodynamic study.

  • schäfer grade [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This parameter can be obtained from urodynamic study.

  • Compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This parameter can be obtained from urodynamic study.


Secondary Outcome Measures:
  • Estimated glomerular filtration rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Urinary protein to creatinine ratio [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • International prostate symptom score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: February 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tamsulosin
The dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months.
Drug: Tamsulosin
Once Daily 0.2mg per oral for 6 months
Other Names:
  • Harnal D
  • Tamsnal

Detailed Description:

Urodynamic parameters including maximal flow rate, compliance (infused volume gradient divided by bladder pressure gradient during cystometry), maximal detrusor pressure, bladder outlet obstruction index and Schäfer grade will be checked.

Estimated glomerular filtration rate and urinary protein to creatinine ratio will be checked.

International prostate symptom score will be checked.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with low urinary tract symptoms aged between 40 and 80
  • Estimated glomerular filtration rate < 60 or evidence of proteinuria
  • Bladder outlet obstruction index > 40, Schäfer grade 2 or more, maximal flow rate lower than 10 cc/s or postvoid residual urine > 100cc

Exclusion Criteria:

  • Bladder outlet obstruction index less than 40, Schäfer grade 0 or 1, maximal flow rate higher than 10 ml/s and postvoid residual urine less than 100cc
  • Want surgical procedure
  • Evidence of prostate cancer or bladder cancer
  • Major depressive disorder, Dementia, Parkinson's disease or neurological deficits
  • History of pelvic irradiation
  • Uncontrolled diabetes mellitus or hypertension
  • Symptomatic orthostatic hypotension
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033798

Contacts
Contact: Seung-Ju Lee, MD, PhD 82-31-249-8305 lee.seungju@gmail.com
Contact: Dong Sup Lee, MD, PhD 82-31-249-8276 lds@catholic.ac.kr

Locations
Korea, Republic of
St. Vincent's Hospital Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Contact: Seung-Ju Lee Lee, MD, PhD    82-31-249-8305    lee.seungju@gmail.com   
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Study Chair: Seung-Ju Lee, MD, PhD The Catholic University of Korea
Principal Investigator: Dong Sup Lee, MD, PhD The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Seung-Ju Lee, Senior researcher, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02033798     History of Changes
Other Study ID Numbers: L201401N2
Study First Received: January 8, 2014
Last Updated: January 15, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Urodynamics
Glomerular Filtration Rate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Kidney Failure, Chronic
Renal Insufficiency
Genital Diseases, Male
Kidney Diseases
Pathologic Processes
Prostatic Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Tamsulosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 27, 2014