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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
194
Samsung Medical Center
Seoul, South Korea
Changes in patients' symptom questionnaires
international prostate symptom score (IPSS) change, except QOL domain scores
Time frame: from baseline to 8 weeks of treatment
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
Time frame: 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
Benefit, Satisfaction, and Willingness to Continue (BSW) questions
Time frame: 8 weeks after treatment
Score of global response assessment for Korean, GRA-K
Time frame: 8 weeks after treatment
Treatment satisfaction question, TSQ
Time frame: 8 weeks after treatment
safety evaluation : incidence and severity of adverse events
Time frame: up to 8 weeks
change in each domain scores of IPSS
Time frame: up to 8 weeks
change in number of urinary frequency, nocturia
Time frame: up to 8weeks
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