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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Seung-Ju Lee, The Catholic University of Korea.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Seung-Ju Lee, The Catholic University of Korea Identifier:
First received: January 8, 2014
Last updated: January 15, 2014
Last verified: January 2014
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 Seung-Ju Lee, The Catholic University of Korea:

Primary Outcome Measures:
  • Maximal flow rate [ Time Frame: 6 months ]
    This parameter can be obtained from urodynamic study.

  • Maximal detrusor pressure [ Time Frame: 6 months ]
    This parameter can be obtained from urodynamic study.

  • Bladder outlet obstruction index [ Time Frame: 6 months ]
    This parameter can be obtained from urodynamic study.

  • schäfer grade [ Time Frame: 6 months ]
    This parameter can be obtained from urodynamic study.

  • Compliance [ Time Frame: 6 months ]
    This parameter can be obtained from urodynamic study.

Secondary Outcome Measures:
  • Estimated glomerular filtration rate [ Time Frame: 6 months ]
  • Urinary protein to creatinine ratio [ Time Frame: 6 months ]

Other Outcome Measures:
  • International prostate symptom score [ Time Frame: 6 months ]

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.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT02033798

Contact: Seung-Ju Lee, MD, PhD 82-31-249-8305
Contact: Dong Sup Lee, MD, PhD 82-31-249-8276

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   
Sponsors and Collaborators
The Catholic University of Korea
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

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

Keywords provided by Seung-Ju Lee, The Catholic University of Korea:
Glomerular Filtration Rate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Renal Insufficiency
Kidney Failure, Chronic
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on May 25, 2017