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

Completed

• Conditions: Nocturia
• Interventions: Behavioral: SyBeMeP (Systemized Behavioural Modification education Program)

• Registration Number: NCT01576900
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-02-13
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-13
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combination group	SyBeMeP (Systemized Behavioural Modification education Program)	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.

Primary Outcome Measures

Name	Time	Method
Decrease in urinary frequency (No. of nocturia)	baseline, 2 week, 1 month, and 3 months

Secondary Outcome Measures

Name	Time	Method
Voiding diary indices	baseline, 2 weeks, 1 month and 3 months
IPSS	baseline, 2 weeks, 1 month and 3 months
patient's satisfaction on the education	baseline, 2 weeks, 1 month and 3 months
ICIQ-nocturia	baseline, 2 weeks, 1 month and 3 months
patient's perception of bladder condition (PPTB)	baseline, 2 weeks, 1 month and 3 months

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of