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

Nocturia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576900
• Other study ID #: Nocturia-SBMP
• Status: Completed
• Phase: N/A
• First received: February 13, 2012
• Last updated: November 19, 2014
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nocturia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ferring Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in urinary frequency (No. of nocturia)		baseline, 2 week, 1 month, and 3 months	No
Secondary	Voiding diary indices		baseline, 2 weeks, 1 month and 3 months	No
Secondary	IPSS		baseline, 2 weeks, 1 month and 3 months	No
Secondary	ICIQ-nocturia		baseline, 2 weeks, 1 month and 3 months	No
Secondary	patient's perception of bladder condition (PPTB)		baseline, 2 weeks, 1 month and 3 months	No
Secondary	patient's satisfaction on the education		baseline, 2 weeks, 1 month and 3 months	No