Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia

NCT ID: NCT02034604

Last Updated: 2019-12-02

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-08-31

Brief Summary

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This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.

Detailed Description

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Conditions

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Neurogenic Lower Urinary Tract Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Naftopidil Group

Naftopidil medication patients

Group Type EXPERIMENTAL

Naftofidil

Intervention Type DRUG

Tamsulosin Goup

Tamsulosin medication patients

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Interventions

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Naftofidil

Intervention Type DRUG

Tamsulosin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female aged 20 years old and above (upper limit of age: 80 years old)
2. patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
3. a+b

1. IPSS ≥ 12 and QoL ≥ 3
2. Maximum Flow Rate \<15 mL/s (Voiding volume) ≥ 120mL)
4. Ability and willingness to correctly complete the micturition diary and questionnaire
5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria

1. In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
2. In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
3. In female, the history of anti-incontinence operation.
4. Patients with cancer of any type including cancer of the prostate or bladder
5. Patients with urethral stricture or bladder neck contracture
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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KYU-SUNG LEE

professor,MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2013-02-043

Identifier Type: -

Identifier Source: org_study_id

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