Neurogenic Lower Urinary Tract Dysfunction
Conditions
Keywords
Naftopidil, safety
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.
Interventions
DRUGNaftofidil
DRUGTamsulosin
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patients' symptom questionnaires | from baseline to 8 weeks of treatment | international prostate symptom score (IPSS) change, except QOL domain scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in uroflow parameters | 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 |
| 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 | — |
| change in number of urinary frequency, nocturia | up to 8weeks | — |
| 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 | — |
| Score of global response assessment for Korean, GRA-K | 8 weeks after treatment | — |
Countries
South Korea
Outcome results
None listed