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

NCT ID: NCT01576900

Last Updated: 2014-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-10-31

Brief Summary

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.

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.

Conditions

Nocturia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Desmopressin monotherapy

Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction

No interventions assigned to this group

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.

SyBeMeP (Systemized Behavioural Modification education Program)

Intervention Type: BEHAVIORAL

• 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seung-June Oh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung Yong Cho, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 21826726 (View on PubMed)

Other Identifiers

Nocturia-SBMP

Identifier Type: -

Identifier Source: org_study_id