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

Overview

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.

Full Title of Study: “Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Catholic University of Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Seung-Ju Lee, Senior researcher – The Catholic University of Korea
  • Overall Official(s)
    • Seung-Ju Lee, MD, PhD, Study Chair, The Catholic University of Korea
    • Dong Sup Lee, MD, PhD, Principal Investigator, The Catholic University of Korea
  • Overall Contact(s)
    • Seung-Ju Lee, MD, PhD, 82-31-249-8305, lee.seungju@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.