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
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJanuary 17, 2014
January 1, 2014
1.9 years
January 8, 2014
January 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Maximal flow rate
This parameter can be obtained from urodynamic study.
6 months
Maximal detrusor pressure
This parameter can be obtained from urodynamic study.
6 months
Bladder outlet obstruction index
This parameter can be obtained from urodynamic study.
6 months
schäfer grade
This parameter can be obtained from urodynamic study.
6 months
Compliance
This parameter can be obtained from urodynamic study.
6 months
Secondary Outcomes (2)
Estimated glomerular filtration rate
6 months
Urinary protein to creatinine ratio
6 months
Other Outcomes (1)
International prostate symptom score
6 months
Study Arms (1)
Tamsulosin
EXPERIMENTALThe dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Seung-Ju Lee, MD, PhD
The Catholic University of Korea
- PRINCIPAL INVESTIGATOR
Dong Sup Lee, MD, PhD
The Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior researcher
Study Record Dates
First Submitted
January 8, 2014
First Posted
January 13, 2014
Study Start
February 1, 2014
Primary Completion
January 1, 2016
Study Completion
June 1, 2016
Last Updated
January 17, 2014
Record last verified: 2014-01