The Effect of Daily Tamsulosin 0.2mg Administration on Renal Function in Patients With Benign Prostatic Hyperplasia
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ClinicalTrials.gov Identifier: NCT02033798 |
Recruitment Status
: Unknown
Verified January 2014 by Seung-Ju Lee, The Catholic University of Korea.
Recruitment status was: Not yet recruiting
First Posted
: January 13, 2014
Last Update Posted
: January 17, 2014
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Condition or disease | Intervention/treatment | Phase |
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Chronic Kidney Failure Prostatic Hyperplasia | Drug: Tamsulosin | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 34 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure |
Study Start Date : | February 2014 |
Estimated Primary Completion Date : | January 2016 |
Estimated Study Completion Date : | June 2016 |
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.
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Drug: Tamsulosin
Once Daily 0.2mg per oral for 6 months
Other Names:
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- 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.
- Estimated glomerular filtration rate [ Time Frame: 6 months ]
- Urinary protein to creatinine ratio [ Time Frame: 6 months ]
- International prostate symptom score [ Time Frame: 6 months ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033798
Contact: Seung-Ju Lee, MD, PhD | 82-31-249-8305 | lee.seungju@gmail.com | |
Contact: Dong Sup Lee, MD, PhD | 82-31-249-8276 | lds@catholic.ac.kr |
Korea, Republic of | |
St. Vincent's Hospital | Not yet recruiting |
Suwon, Gyeonggi-do, Korea, Republic of, 442-723 | |
Contact: Seung-Ju Lee Lee, MD, PhD 82-31-249-8305 lee.seungju@gmail.com |
Study Chair: | Seung-Ju Lee, MD, PhD | The Catholic University of Korea | |
Principal Investigator: | Dong Sup Lee, MD, PhD | The Catholic University of Korea |
Responsible Party: | Seung-Ju Lee, Senior researcher, The Catholic University of Korea |
ClinicalTrials.gov Identifier: | NCT02033798 History of Changes |
Other Study ID Numbers: |
L201401N2 |
First Posted: | January 13, 2014 Key Record Dates |
Last Update Posted: | January 17, 2014 |
Last Verified: | January 2014 |
Keywords provided by Seung-Ju Lee, The Catholic University of Korea:
Urodynamics Glomerular Filtration Rate |
Additional relevant MeSH terms:
Hyperplasia Prostatic Hyperplasia Renal Insufficiency Kidney Failure, Chronic Pathologic Processes Prostatic Diseases Genital Diseases, Male Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |
Tamsulosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |