- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576900
The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Desmopressin monotherapy
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day)
+ simple instruction
|
|
Combination group
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. |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in urinary frequency (No. of nocturia)
Time Frame: baseline, 2 week, 1 month, and 3 months
|
baseline, 2 week, 1 month, and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Voiding diary indices
Time Frame: baseline, 2 weeks, 1 month and 3 months
|
baseline, 2 weeks, 1 month and 3 months
|
IPSS
Time Frame: baseline, 2 weeks, 1 month and 3 months
|
baseline, 2 weeks, 1 month and 3 months
|
ICIQ-nocturia
Time Frame: baseline, 2 weeks, 1 month and 3 months
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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
|
baseline, 2 weeks, 1 month and 3 months
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patient's satisfaction on the education
Time Frame: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Sung Yong Cho, M.D.,Ph.D., Seoul National University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nocturia-SBMP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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