The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
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|ClinicalTrials.gov Identifier: NCT01576900|
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : November 20, 2014
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.
|Condition or disease||Intervention/treatment|
|Nocturia||Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)|
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.
|Study Type :||Observational|
|Actual Enrollment :||124 participants|
|Observational Model:||Case Control|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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.
Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)
- Decrease in urinary frequency (No. of nocturia) [ Time Frame: baseline, 2 week, 1 month, and 3 months ]
- Voiding diary indices [ Time Frame: baseline, 2 weeks, 1 month and 3 months ]
- IPSS [ Time Frame: baseline, 2 weeks, 1 month and 3 months ]
- ICIQ-nocturia [ Time Frame: baseline, 2 weeks, 1 month and 3 months ]
- patient's perception of bladder condition (PPTB) [ Time Frame: baseline, 2 weeks, 1 month and 3 months ]
- patient's satisfaction on the education [ Time Frame: baseline, 2 weeks, 1 month and 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576900
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Study Director:||Sung Yong Cho, M.D.,Ph.D.||Seoul National University Hospital|