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

Not Applicable

• Conditions: Chronic Kidney Failure; Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin

• Registration Number: NCT02033798
• Lead Sponsor: The Catholic University of Korea

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 Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-17
• Study Start: 2014-02
• Primary Completion: 2016-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tamsulosin	Tamsulosin	The dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months.

Primary Outcome Measures

Name	Time	Method
Bladder outlet obstruction index	6 months	This parameter can be obtained from urodynamic study.
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.
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

Name	Time	Method
Estimated glomerular filtration rate	6 months
Urinary protein to creatinine ratio	6 months

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of