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

November 28, 2019 updated by: KYU-SUNG LEE, Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naftopidil Group
Naftopidil medication patients
Drug: Naftofidil
Active Comparator: Tamsulosin Goup
Tamsulosin medication patients
Drug: Tamsulosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patients' symptom questionnaires
Time Frame: from baseline to 8 weeks of treatment
international prostate symptom score (IPSS) change, except QOL domain scores
from baseline to 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in uroflow parameters
Time Frame: from baseline to 8 weeks of treatment
maximal flow rate, mean flow rate, voided volume and Changes in uroflowmetry parameters : maximal flow rate,mean flow rate, voided volume and PVR
from baseline to 8 weeks of treatment
Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.
Time Frame: from baseline to 8 weeks of treatment
from baseline to 8 weeks of treatment
Benefit, Satisfaction, and Willingness to Continue (BSW) questions
Time Frame: 8 weeks after treatment
8 weeks after treatment
Score of global response assessment for Korean, GRA-K
Time Frame: 8 weeks after treatment
8 weeks after treatment
Treatment satisfaction question, TSQ
Time Frame: 8 weeks after treatment
8 weeks after treatment
safety evaluation : incidence and severity of adverse events
Time Frame: up to 8 weeks
up to 8 weeks
change in each domain scores of IPSS
Time Frame: up to 8 weeks
up to 8 weeks
change in number of urinary frequency, nocturia
Time Frame: up to 8weeks
up to 8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-02-043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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