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

Prostatic Hyperplasia Clinical Trial

Official title:

Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02033798
• Other study ID #: L201401N2
• Status: Not yet recruiting
• Phase: N/A
• First received: January 8, 2014
• Last updated: January 15, 2014
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2014
• Source: The Catholic University of Korea
• Contact: Seung-Ju Lee, MD, PhD
• Phone: 82-31-249-8305
• Email: lee.seungju[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Hyperplasia
• Kidney Failure, Chronic
• Prostatic Hyperplasia
• Renal Insufficiency

Intervention

Drug:
• Tamsulosin
Once Daily 0.2mg per oral for 6 months

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International prostate symptom score		6 months	No
Primary	Maximal flow rate	This parameter can be obtained from urodynamic study.	6 months	No
Primary	Maximal detrusor pressure	This parameter can be obtained from urodynamic study.	6 months	No
Primary	Bladder outlet obstruction index	This parameter can be obtained from urodynamic study.	6 months	No
Primary	schäfer grade	This parameter can be obtained from urodynamic study.	6 months	No
Primary	Compliance	This parameter can be obtained from urodynamic study.	6 months	No
Secondary	Estimated glomerular filtration rate		6 months	No
Secondary	Urinary protein to creatinine ratio		6 months	No