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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftopidil Group | Experimental | Naftopidil medication patients |
|
| Tamsulosin Goup | Active Comparator | Tamsulosin medication patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftofidil | Drug |
| ||
| Tamsulosin |
| 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 |
| 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%. |
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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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 130-710 | South Korea |
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|
| 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 |
| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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