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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Failure, Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin<br>The dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months. | Drug: Tamsulosin<br>* Once Daily 0.2mg per oral for 6 months<br>* Other names: Tamsnal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated glomerular filtration rate |  | 6 months | 
| Urinary protein to creatinine ratio |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urodynamics, Glomerular Filtration Rate