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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Failure; Prostatic Hyperplasia	Drug: Tamsulosin	Not Applicable

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	34 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure
Study Start Date :	February 2014
Estimated Primary Completion Date :	January 2016
Estimated Study Completion Date :	June 2016

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Maximal flow rate [ Time Frame: 6 months ]
   This parameter can be obtained from urodynamic study.
2. Maximal detrusor pressure [ Time Frame: 6 months ]
   This parameter can be obtained from urodynamic study.
3. Bladder outlet obstruction index [ Time Frame: 6 months ]
   This parameter can be obtained from urodynamic study.
4. schäfer grade [ Time Frame: 6 months ]
   This parameter can be obtained from urodynamic study.
5. Compliance [ Time Frame: 6 months ]
   This parameter can be obtained from urodynamic study.

Secondary Outcome Measures :

1. Estimated glomerular filtration rate [ Time Frame: 6 months ]
2. Urinary protein to creatinine ratio [ Time Frame: 6 months ]

Other Outcome Measures:

1. International prostate symptom score [ Time Frame: 6 months ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes 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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Seung-Ju Lee, Senior researcher, The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT02033798 History of Changes
Other Study ID Numbers:	L201401N2
First Posted:	January 13, 2014
Last Update Posted:	January 17, 2014
Last Verified:	January 2014

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

Urodynamics; Glomerular Filtration Rate

Additional relevant MeSH terms:

Hyperplasia; Prostatic Hyperplasia; Renal Insufficiency; Kidney Failure, Chronic; Pathologic Processes; Prostatic Diseases; Genital Diseases, Male; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic	Tamsulosin; 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