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

Primary Purpose

Chronic Kidney Failure, Prostatic Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring Urodynamics, Glomerular Filtration Rate

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tamsulosin

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Estimated glomerular filtration rate
Urinary protein to creatinine ratio

Full Information

First Posted
January 8, 2014
Last Updated
January 15, 2014
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02033798
Brief Title
The Effect of Daily Tamsulosin 0.2mg Administration on Renal Function in Patients With Benign Prostatic Hyperplasia
Official Title
Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure, Prostatic Hyperplasia
Keywords
Urodynamics, Glomerular Filtration Rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin
Arm Type
Experimental
Arm Description
The dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Harnal D, Tamsnal
Intervention Description
Once Daily 0.2mg per oral for 6 months
Primary Outcome Measure Information:
Title
Maximal flow rate
Description
This parameter can be obtained from urodynamic study.
Time Frame
6 months
Title
Maximal detrusor pressure
Description
This parameter can be obtained from urodynamic study.
Time Frame
6 months
Title
Bladder outlet obstruction index
Description
This parameter can be obtained from urodynamic study.
Time Frame
6 months
Title
schäfer grade
Description
This parameter can be obtained from urodynamic study.
Time Frame
6 months
Title
Compliance
Description
This parameter can be obtained from urodynamic study.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Estimated glomerular filtration rate
Time Frame
6 months
Title
Urinary protein to creatinine ratio
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
International prostate symptom score
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Ju Lee, MD, PhD
Phone
82-31-249-8305
Email
lee.seungju@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Sup Lee, MD, PhD
Phone
82-31-249-8276
Email
lds@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Ju Lee, MD, PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dong Sup Lee, MD, PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Ju Lee Lee, MD, PhD
Phone
82-31-249-8305
Email
lee.seungju@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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