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

History of Changes

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:

MedlinePlus related topics: Enlarged Prostate (BPH) Kidney Failure

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

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:


Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Hyperplasia Prostatic Hyperplasia Genital Diseases, Male Kidney Diseases Pathologic Processes Prostatic Diseases 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 March 03, 2015

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