The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia

Study Overview
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Brief Summary
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In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes. Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel.

Detailed Description
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One of main reason of nocturia is known as nocturnal polyuria. For the treatment of nocturia caused by overactive bladder, the combined therapy of anticholinergics plus behavioural modification has been established as the first line therapy. However, nocturia mainly comes from polyuria has been treated with desmopressin pharmacotherapy and the effect of behaviour modification education has not yet evaluated. Therefore, in this study, short term synergistic effect of combinational treatment of desmopressin and SyBeMeP (Systemized Behavioral Modification education Program) comparing desmopressin monotherpy will be evaluated in patients with nocturia. Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP. Patients will be randomized and assigned to each group at the ratio of 1:1. At screening visit, flowmetry and residual urine measurement, Complete Blood Count (CBC), atypical diabetes mellitus (ADM), electrolytes, urinalysis micro, urine concentration, and demographic examination will be done. Voiding diary will be distributed. At 2nd visit, patients will be randomized and each treatment will be initiated. IPSS, ICIQ-nocturia, and PPTB will be completed. Voiding diary will be distributed. At 3rd visit (2 weeks after from 2nd visit): IPSS, ICIQ-nocturia, and PPTB will be completed. Assess the treatment outcome including voiding diary analysis.

Conditions
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Nocturia

Intervention / Treatment
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* Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient with nocturia, who visited department of urology as outpatient Have not been treated with desmopressin for at least 6 months before Exclusion Criteria: Sleep disorder, history of medication for voiding, diabetes insipidus, diabetes mellitus, cardiovascular disease, voiding difficulties (including residual urine of more than 100ml), small bladder capacity, overactive bladder, illiteracy, psychiatric disorder and having no intention to be enrolled by written agreement

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Desmopressin monotherapy<br>Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction | |
| Combination group<br>Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP * Patients will be randomized and assigned to each group at the ratio of 1:1. | Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)<br>* Standard video material will be developed to minimize variation of outcomes caused by differences in contents at each trial site. Video material will be self-study program for PC with running time around 20 minutes. Contents will cover pathophysiology, diagnosis and treatment process, and be easy to understand for everyone with variety of examples. In treatment part, it will describe general principles of behavioural therapy (Adjustment of timing of fluid intake, Reducing alcohol and caffeine, Improving sleep hygiene including moderate exercise, room temperature, noise and lighting. if necessary, compressive stocking, late afternoon nap and leg elevation would be added) During trial, patients will watch SYBeMeP at a specially prepared separate room with computer. After watching the video, check-list on take-home message will be recorded by patients at the site to confirm patients' awareness after education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in urinary frequency (No. of nocturia) |  | baseline, 2 week, 1 month, and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voiding diary indices |  | baseline, 2 weeks, 1 month and 3 months | 
| IPSS |  | baseline, 2 weeks, 1 month and 3 months | 
| ICIQ-nocturia |  | baseline, 2 weeks, 1 month and 3 months | 
| patient's perception of bladder condition (PPTB) |  | baseline, 2 weeks, 1 month and 3 months | 
| patient's satisfaction on the education |  | baseline, 2 weeks, 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavior therapy, nocturia, polyuria