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

NCT ID: NCT02033798

Last Updated: 2014-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-06-30

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.

Conditions

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Chronic Kidney Failure Prostatic Hyperplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tamsulosin

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

Group Type EXPERIMENTAL

Tamsulosin

Intervention Type DRUG

Once Daily 0.2mg per oral for 6 months

Interventions

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Tamsulosin

Once Daily 0.2mg per oral for 6 months

Intervention Type DRUG

Other Intervention Names

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Harnal D Tamsnal

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Seung-Ju Lee

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung-Ju Lee, MD, PhD

Role: STUDY_CHAIR

The Catholic University of Korea

Dong Sup Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Seung-Ju Lee, MD, PhD

Role: CONTACT

82-31-249-8305

Dong Sup Lee, MD, PhD

Role: CONTACT

82-31-249-8276

Facility Contacts

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Seung-Ju Lee Lee, MD, PhD

Role: primary

82-31-249-8305

Other Identifiers

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L201401N2

Identifier Type: -

Identifier Source: org_study_id

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