The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Study type: Observational

Summary: 
      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: 
      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.
    

Intervention name(s): SyBeMeP (Systemized Behavioural Modification education Program)
Intervention type(s): Behavioral
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Korean patients with nocturia regardless of age and gender
      
Keywords: behavior therapy; nocturia; polyuria