None listed
Conditions
Interventions
Drug : 1.Assignment to arms
> Control arm: alpha-blocker + desmopressin 0.1 mg
> Treatment arm: alpha-blocker + desmopressin 0.1 mg + imidapfenacin 0.1 mg
? Alpha-blocker: Tamsurosin 0.2mg
2. R
Sponsors
Chungbuk National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: For inclusion in the study, all of the following inclusion criteria must be fulfilled: 1) Male subjects aged = 50 years 2) Overactive bladder symptoms (4 = OABSS & 2 = Question 3) 3) Maximum flow rate (Qmax) 4 ml / sec or more and 20 ml / sec or less 4) Minimum urine volume more than 125 ml 5) Residual urine volume less than 100 ml 6) urination One or more times of nocturnal nighttime urine, nocturnal polyuria index (NPi) 30% or more 7) Be willing and able to provide written informed consent for the study
Exclusion criteria
Exclusion criteria: The subjects must be excluded from participating in the study if the subject: 1) Acute urinary retention anamnesis within 3 months 2) Serum total PSA > 10 ng / ml (if more than 4 ng / ml, less than 10 ng / ml, you can participatie in the study only if prostate cancer is excluded form the prostate biopsy within 6 months before screening) 3) Anatomical abnormality of lower urinary tract (urethral stricture, diverticulum, bladder neck contraction, etc.) 4) Clinical conditions affecting urination (neurogenic bladder, CP / CPPS, urinary tract infection, etc.) 5) Unstable and significant medical conditions, including: - Within 6 months before screening Unstable angina, myocardial infarction, cerebrovascular disease - Previous malignant tumors including skin basal cell carcinoma within the last 5 years - diabetes, peptic ulcer disease not controlled by medical management - Severe liver disease - Renal insufficiency history, renal disease (when serum creatinine exceeds 1.4 mg / dl) - Conditions that are expected to cause serious adverse reactions due to the clinical trial drug 6) If participation is impossible due to the judgment of principal Investigatior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of improving the nighttime urine (the number of nocturnal urine decreases and the difference in urine volume can be compared) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of quality of life according to the effect of improving nighttime urine;Evaluation of frequency of urination and improvement of weekly urinary symptoms | — |
Countries
Korea, Republic of
Contacts
Public ContactYong Kim
Chungbuk National University Hospital
Outcome results
None listed