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

Sponsor

The Catholic University of Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT02033798

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

N/A

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 :

Feb 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Primary Outcome Measures

Maximal flow rate [6 months]
This parameter can be obtained from urodynamic study.
Maximal detrusor pressure [6 months]
This parameter can be obtained from urodynamic study.
Bladder outlet obstruction index [6 months]
This parameter can be obtained from urodynamic study.
schäfer grade [6 months]
This parameter can be obtained from urodynamic study.
Compliance [6 months]
This parameter can be obtained from urodynamic study.

Secondary Outcome Measures

Estimated glomerular filtration rate [6 months]
Urinary protein to creatinine ratio [6 months]

Other Outcome Measures

International prostate symptom score [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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