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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyBeMeP (Systemized Behavioural Modification education Program) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in urinary frequency (No. of nocturia) | baseline, 2 week, 1 month, and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Voiding diary indices | baseline, 2 weeks, 1 month and 3 months | |
| IPSS | baseline, 2 weeks, 1 month and 3 months | |
| ICIQ-nocturia |
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Inclusion Criteria:
Exclusion Criteria:
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Korean patients with nocturia regardless of age and gender
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| Name | Affiliation | Role |
|---|---|---|
| Sung Yong Cho, M.D.,Ph.D. | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21826726 | Background | Cho SY, Lee SL, Kim IS, Koo DH, Kim HJ, Oh SJ. Short-term effects of systematized behavioral modification program for nocturia: a prospective study. Neurourol Urodyn. 2012 Jan;31(1):64-8. doi: 10.1002/nau.21186. Epub 2011 Aug 8. |
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|
| baseline, 2 weeks, 1 month and 3 months |
| patient's perception of bladder condition (PPTB) | baseline, 2 weeks, 1 month and 3 months |
| patient's satisfaction on the education | baseline, 2 weeks, 1 month and 3 months |
| ID | Term |
|---|---|
| D053158 | Nocturia |
| D011141 | Polyuria |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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