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

Study Overview
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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.

Conditions
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Neurogenic Lower Urinary Tract Dysfunction

Intervention / Treatment
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* Drug: Naftofidil
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 20 years old and above (upper limit of age: 80 years old) patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc) a+b IPSS ≥ 12 and QoL ≥ 3 Maximum Flow Rate <15 mL/s (Voiding volume) ≥ 120mL) Ability and willingness to correctly complete the micturition diary and questionnaire 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: In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40) In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2 In female, the history of anti-incontinence operation. Patients with cancer of any type including cancer of the prostate or bladder Patients with urethral stricture or bladder neck contracture

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naftopidil Group<br>Naftopidil medication patients | Drug: Naftofidil<br> <br> |
| Active Comparator: Tamsulosin Goup<br>Tamsulosin medication patients | Drug: Tamsulosin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patients' symptom questionnaires | 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 | 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%. |  | from baseline to 8 weeks of treatment | 
| Benefit, Satisfaction, and Willingness to Continue (BSW) questions |  | 8 weeks after treatment | 
| Score of global response assessment for Korean, GRA-K |  | 8 weeks after treatment | 
| Treatment satisfaction question, TSQ |  | 8 weeks after treatment | 
| safety evaluation : incidence and severity of adverse events |  | up to 8 weeks | 
| change in each domain scores of IPSS |  | up to 8 weeks | 
| change in number of urinary frequency, nocturia |  | up to 8weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naftopidil, safety