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NCT Number: NCT01576900

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Decrease in urinary frequency (No. of nocturia)

    Time frame: baseline, 2 week, 1 month, and 3 months

Secondary outcomes

  1. Voiding diary indices

    Time frame: baseline, 2 weeks, 1 month and 3 months

  2. IPSS

    Time frame: baseline, 2 weeks, 1 month and 3 months

  3. ICIQ-nocturia

    Time frame: baseline, 2 weeks, 1 month and 3 months

  4. patient's perception of bladder condition (PPTB)

    Time frame: baseline, 2 weeks, 1 month and 3 months

  5. patient's satisfaction on the education

    Time frame: baseline, 2 weeks, 1 month and 3 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2012
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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