The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 200
Summary
- Conditions
- Nocturia
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Prospective
Participation Requirements
- Age
- Between 20 years and 80 years
- Gender
- Both males and females
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 trea...
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.
Tracking Information
- NCT #
- NCT01576900
- Collaborators
- Ferring Pharmaceuticals
- Investigators
- Study Director: Sung Yong Cho, M.D.,Ph.D. Seoul National University Hospital