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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02033798
Enrollment
34
Registered
2014-01-13
Start date
2014-02-28
Completion date
2016-06-30
Last updated
2014-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Prostatic Hyperplasia

Keywords

Urodynamics, Glomerular Filtration Rate

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.

Interventions

DRUGTamsulosin

Once Daily 0.2mg per oral for 6 months

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compliance6 monthsThis parameter can be obtained from urodynamic study.
Maximal detrusor pressure6 monthsThis parameter can be obtained from urodynamic study.
Bladder outlet obstruction index6 monthsThis parameter can be obtained from urodynamic study.
schäfer grade6 monthsThis parameter can be obtained from urodynamic study.
Maximal flow rate6 monthsThis parameter can be obtained from urodynamic study.

Secondary

MeasureTime frame
Estimated glomerular filtration rate6 months
Urinary protein to creatinine ratio6 months

Other

MeasureTime frame
International prostate symptom score6 months

Countries

South Korea

Contacts

Primary ContactSeung-Ju Lee, MD, PhD
lee.seungju@gmail.com82-31-249-8305
Backup ContactDong Sup Lee, MD, PhD
lds@catholic.ac.kr82-31-249-8276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026