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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034604
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neurogenic Lower Urinary Tract Dysfunction Drug: Naftofidil Drug: Tamsulosin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : August 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Naftopidil Group
Naftopidil medication patients
 Drug: Naftofidil
Active Comparator: Tamsulosin Goup
Tamsulosin medication patients
 Drug: Tamsulosin


Outcome Measures
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Primary Outcome Measures :
  1. Changes in patients' symptom questionnaires [ Time Frame: from baseline to 8 weeks of treatment ]
    international prostate symptom score (IPSS) change, except QOL domain scores


Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. Benefit, Satisfaction, and Willingness to Continue (BSW) questions [ Time Frame: 8 weeks after treatment ]
  4. Score of global response assessment for Korean, GRA-K [ Time Frame: 8 weeks after treatment ]
  5. Treatment satisfaction question, TSQ [ Time Frame: 8 weeks after treatment ]
  6. safety evaluation : incidence and severity of adverse events [ Time Frame: up to 8 weeks ]
  7. change in each domain scores of IPSS [ Time Frame: up to 8 weeks ]
  8. change in number of urinary frequency, nocturia [ Time Frame: up to 8weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02034604


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 130-710
Sponsors and Collaborators
Samsung Medical Center
More Information
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Responsible Party: KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02034604    
Other Study ID Numbers: 2013-02-043
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
Naftopidil
safety
Additional relevant MeSH terms:
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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