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

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ClinicalTrials.gov Identifier: NCT02033798
Recruitment Status : Unknown
Verified January 2014 by Seung-Ju Lee, The Catholic University of Korea.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2014
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):
Seung-Ju Lee, The Catholic University of Korea

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date January 17, 2014
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02033798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • Estimated glomerular filtration rate [ Time Frame: 6 months ]
  • Urinary protein to creatinine ratio [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 9, 2014)
International prostate symptom score [ Time Frame: 6 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Daily Tamsulosin 0.2mg Administration on Renal Function in Patients With Benign Prostatic Hyperplasia
Official Title  ICMJE Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Failure
  • Prostatic Hyperplasia
Intervention  ICMJE Drug: Tamsulosin
Once Daily 0.2mg per oral for 6 months
Other Names:
  • Harnal D
  • Tamsnal
Study Arms  ICMJE Experimental: Tamsulosin
The dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months.
Intervention: Drug: Tamsulosin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 9, 2014)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02033798
Other Study ID Numbers  ICMJE L201401N2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seung-Ju Lee, The Catholic University of Korea
Study Sponsor  ICMJE The Catholic University of Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Seung-Ju Lee, MD, PhD The Catholic University of Korea
Principal Investigator: Dong Sup Lee, MD, PhD The Catholic University of Korea
PRS Account The Catholic University of Korea
Verification Date January 2014

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