1.<Study Design>
In this study, subjects who had overactive bladder symptoms and who complained more than one nocturnal dysuria were randomly assigned to receive alpha-blocker + Desmopressin 0.1 mg and alpha-blocker + Desmopressin 0.1 mg + Imidafenacin 0.1. The aim of this study was to evaluate the clinical efficacy of the combination therapy in subject gruops . The subjects are visited 5 times in total including the Visit 0 visits. The appropriate subjects will be involved in the clinical study for two months from visit1 to the end of the study (visit 4). During this period, they take the prescribed medication according to the dosage and dosage according to the patient's condition. The subjects are randomly assigned. Chungbuk National University Hospital as the host institution, and it is carried out in 6 institutions in total.

2. <Study Objectives>
Objectives is to compare the efficacy of Desmopressin alone and Imidafenacin combined treatment for symptom improvement in patients with nocturia with irritable bladder symptoms

3. <Sample Size>
A total of 360 people - 180 people will be assigned to each group.

4. <Investigational Medicinal Product and Other Drugs Used in the Trial>
- alpha-blocker + desmopressin 0.1 mg
- alpha-blocker + desmopressin 0.1 mg + Imidafenacin 0.1 mg
※ Alpha-blocker: Tamsurosin 0.2mg

5. <Study Assessments>
1) Assessments
 - Blood chemistry: prostate-specific antigen (PSA), general chemistry (sodium)
 - Uroflowmetry: maximum flow rate, voided volume, post-void residual volume
 - Urinalysis
 - Transrectal ultrasonography 
2) Questionnaire
 - International Prostate Symptom Score (IPSS)
 - Overactive Bladder Symptom Score (OABSS)
 - Sleepiness measurement table (Epworth Sleeping)
 - Frequency volume chart
 - Nocturia Quality of Life Questionnaire (N-QoL)

6. <Analysis Stes>
□ Statistics 
 > Using the data of this study, the following sub-analysis is possible.
   1) In patients with nocturnal symptoms, alpha-blockers + desmopressin vs alpha-blockers + desmopressin + imidafenacin
       Improvement of nighttime urine (comparison of the difference between nighttime urine frequency and night urine volume
   2) Comparison of the quality of life according to the improvement of nighttime urine
       ① Primary Endpoints
         - Improvement of symptoms of nighttime urine (decreased number of times and nighttime requirement)
       ② Secondary Endpoints
         - Evaluation of quality of life by improving symptoms of nocturnal enuresis
       ③ Evaluation of the frequency of urination and improvement of urinary symptoms during the day
□ Safety
 > Safety evaluation variables
    Adverse reactions: Check every visit after drug administration.
    Blood test (Na): Check at visit 0, visit 2, visit 4.
    Signs of vitality (height, weight): Check only at visit 1 (optional)

Treatment

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. Randomization
  > Envelope proceeding: Enclose the prepared random assignment table and distribute it to each institution. 
     The distributed randomized placeholder will be released at the time of enrollment and 
     The target person is registered according to the assignment table.

3. The difference between the test group and the control group was as shown in item 1, the treatment Group was treated with 
   imidafenacin, and the control group combination therapy

Arm Label

Target Number of Participant

Arm Type

Arm Description

> Treatment: alpha-blocker + desmopressin 0.1 mg + imidapfenacin 0.1 mg
  ※ Alpha-blocker: Tamsurosin 0.2mg
> Prescription Frequency: Total 4 times (V1, V2, V3, V4) _V1 (0 weeks), V2 (1 weeks), V3 (4 weeks, +, - 7 days), 
                                      V4 (8 weeks + - 7  days)

Arm Label

Target Number of Participant

Arm Type

Arm Description

Control therapy: alpha-blocker + desmopressin 0.1 mg + imidapfenacin 0.1 mg
                       ※ Alpha-blocker: Tamsurosin 0.2mg
> Prescription Frequency: Total 4 times (V1, V2, V3, V4) _V1 (0 weeks), V2 (1 weeks), V3 (4 weeks, +, - 7 days), 
                                      V4 (8 weeks + - 7  days)

Gender

Age

Description

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

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

The effect of improving the nighttime urine (the number of nocturnal urine decreases and the difference in urine volume can be compared)

V0,3, 4

Evaluation of quality of life according to the effect of improving nighttime urine

V0,3, 4

Evaluation of frequency of urination and improvement of weekly urinary symptoms

V0,3 (optional), 4

This study was conducted with the group taking alpha blocker (tamsulosin 0.2 mg) + desmopressin 0.1 mg and alpha blocker (tamsulosin 0.2 mg) + desmo This is a prospective randomized study conducted to compare and evaluate the clinical effects of the pressin 0.1mg + imidafenacin 0.1mg combination group. was carried out over A total of 68 questionnaires were collected from 3 institutions, but 8 were excluded due to non-conformity with the selection exclusion criteria, and a total of 60 subjects were included in the efficacy evaluation subject group.
The primary purpose of this study is to evaluate the improvement of symptoms of nocturia, and the secondary objective is to evaluate the quality of life according to the improvement of symptoms of nocturia. For this purpose, the subjects of each control and test group after administration of alpha blocker (tamsulosin 0.2mg) + desmopressin 0.1mg and alpha blocker (tamsulosin 0.2mg) + desmopressin 0.1mg + imidafenacin 0.1mg The frequency of nocturia, the amount of nocturia, the frequency of urination during the week, and the quality of life were evaluated. As a result of examining the changes in the 72-hour voiding diary, OABSS, IPSS, and N-QoL, at 8 weeks at the end of the test, both the control group and the test group showed a statistically significant improvement in nocturia symptoms. A better improvement effect could be confirmed. However, there was no significant difference between the control group and the test group in changes in the number of daytime urine and N-QoL.
Both the alpha blocker (tamsulosin 0.2 mg) + desmopressin 0.1 mg and the alpha blocker (tamsulosin 0.2 mg) + desmopressin 0.1 mg + imidafenacin 0.1 mg combined administration showed improvement in the nocturia symptoms of the subjects. and the improvement effect was greater when imidafenacin was administered in combination. Therefore, alpha blocker (tamsulosin 0.2mg) + desmopressin 0.1mg + imidafenacin Concomitant administration of 0.1 mg is considered to be effective in improving the symptoms of nocturia in patients with benign prostatic hyperplasia.