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

NCT01576900 | Completed DMC

• 1 other identifier: Nocturia-SBMP
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturia

Keywords

behavior therapy; nocturia; polyuria

Outcome Measures

Primary Outcomes (1)

• Decrease in urinary frequency (No. of nocturia)

  baseline, 2 week, 1 month, and 3 months

Secondary Outcomes (5)

• Voiding diary indices

  baseline, 2 weeks, 1 month and 3 months

• IPSS

  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

• patient's satisfaction on the education

  baseline, 2 weeks, 1 month and 3 months

Study Arms (2)

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)

Interventions

SyBeMeP (Systemized Behavioural Modification education Program) 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.

Combination group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korean patients with nocturia regardless of age and gender

You may qualify if:

• A patient with nocturia, who visited department of urology as outpatient
• Have not been treated with desmopressin for at least 6 months before

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related 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.

  PMID: 21826726 BACKGROUND

MeSH Terms

Conditions

Nocturia; Polyuria

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sung Yong Cho, M.D.,Ph.D.

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: April 13, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

KR (1)