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The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia

This study is not yet open for participant recruitment.
Verified April 2012 by Seoul National University Hospital
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Seung-June Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01576900
First received: February 13, 2012
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Nocturia
 Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Decrease in urinary frequency (No. of nocturia) [ Time Frame: baseline, 2 week, 1 month, and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Voiding diary indices [ Time Frame: baseline, 2 weeks, 1 month and 3 months ] [ Designated as safety issue: No ]
  • IPSS [ Time Frame: baseline, 2 weeks, 1 month and 3 months ] [ Designated as safety issue: No ]
  • ICIQ-nocturia [ Time Frame: baseline, 2 weeks, 1 month and 3 months ] [ Designated as safety issue: No ]
  • patient's perception of bladder condition (PPTB) [ Time Frame: baseline, 2 weeks, 1 month and 3 months ] [ Designated as safety issue: No ]
  • patient's satisfaction on the education [ Time Frame: baseline, 2 weeks, 1 month and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Korean patients with nocturia regardless of age and gender

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576900

Contacts
Contact: Sung Yong Cho, M.D., Ph.D. +82-2-870-2394 kmoretry@daum.net
Contact: Seung June Oh, M.D., Ph.D. +82-2-2072-2428 sjo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sung Yong Cho, M.D.,Ph.D.     +82-2-870-2394     kmoretry@daum.net    
Sponsors and Collaborators
Seoul National University Hospital
Ferring Pharmaceuticals
Investigators
Study Director: Sung Yong Cho, M.D.,Ph.D. Seoul National University Hospital
  More Information

Publications:

Responsible Party: Seung-June Oh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01576900     History of Changes
Other Study ID Numbers: Nocturia-SBMP
Study First Received: February 13, 2012
Last Updated: April 11, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
behavior therapy
nocturia
polyuria

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013