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

January 15, 2014 updated by: Seung-Ju Lee, The Catholic University of Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
        • St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal flow rate
Time Frame: 6 months
This parameter can be obtained from urodynamic study.
6 months
Maximal detrusor pressure
Time Frame: 6 months
This parameter can be obtained from urodynamic study.
6 months
Bladder outlet obstruction index
Time Frame: 6 months
This parameter can be obtained from urodynamic study.
6 months
schäfer grade
Time Frame: 6 months
This parameter can be obtained from urodynamic study.
6 months
Compliance
Time Frame: 6 months
This parameter can be obtained from urodynamic study.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimated glomerular filtration rate
Time Frame: 6 months
6 months
Urinary protein to creatinine ratio
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
International prostate symptom score
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L201401N2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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