An observational study in Nocturia, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-20.
Sponsored by Seoul National University Hospital · Observational
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.
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.
124 studies on the registry are indexed under Nocturia; 24 are open to participants now.
This study's enrollment of 124 is below the median of 275 across 24 observational studies indexed under Nocturia.
Browse Nocturia studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Korean patients with nocturia regardless of age and gender
Exclusion Criteria:
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)
* 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.
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
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital