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Necessity for Repetitive Education of Behavioral Modification

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01280279
First received: January 17, 2011
Last updated: January 19, 2011
Last verified: January 2011
History of Changes
  Purpose

Few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturnal polyuria (NPU). The aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with NPU and to show whether a single education for behavioral modification is sufficient for the patients.


Condition Intervention
Patients Who Had the Urine Volume at Nighttime More Than One Third of Total Daily Urine Volume (NPU) and Voided More Than Two Times at Nighttime (Nocturia)
 Other: education for behavioral modification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short-term Effects of Systematized Behavioral Modification Program (SBMP) for Nocturia: A Prospective Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • decrease of nocturnal urine volume [ Time Frame: 1 month after education ] [ Designated as safety issue: No ]
    The variables of FVC were prospectively collected at the time of the first visit using frequency-volume chart (FVC) for 2 days. On their second visit two weeks later, if they had nocturnal polyuria, they received the first education for behavioral modification and to fill up FVC again. When they had no improvement of nocturnal polyuria on the third visit one month later, they finally received the second education and they were recommended to fill up the FVC.


Secondary Outcome Measures:
  • improvement of symptoms and quality of life [ Time Frame: 1 month after education ] [ Designated as safety issue: No ]
    The variables of FVC were prospectively collected at the time of the first visit using frequency-volume chart (FVC) for 2 days. On their second visit two weeks later, if they had nocturnal polyuria, they received the first education for behavioral modification and to fill up questionnaires again. When they had no improvement of nocturnal polyuria on the third visit one month later, they finally received the second education and they were recommended to fill up the FVC and questionnaires.


Enrollment: 104
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
group with nocturnal polyuria and nocturia
Patients were enrolled when they had the urine volume at nighttime more than one third of total daily urine volume (NPU) and voided more than two times at nighttime (nocturia)
 Other: education for behavioral modification
a systematized 30-minutes education program for behavioral modification (SBMP) by watching videos and discussion with a specialized continence nurse practitioner.

Detailed Description:

Even though behavioral modification therapy seems to be effective, it is not usually recommended for patients with nocturia because much patience and understanding is required for the patients to follow the therapy. Few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturia and nocturnal polyuria (NPU). Furthermore, no report demonstrated the evidence about how many times or how long the education for behavioral therapy should be performed and how long will the education effect would continue. The aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with NPU and to show whether a single education for behavioral modification is sufficient for the patients.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who had the urine volume at nighttime more than one third of total daily urine volume (NPU) and voided more than two times at nighttime (nocturia)

Criteria

Inclusion Criteria:

  • the urine volume at nighttime more than one third of total daily urine volume
  • voided more than two times at nighttime

Exclusion Criteria:

  • postvoid urine volume more than 100 ml
  • sleep disturbance including sleep apnea
  • diabetes mellitus
  • diabetes insipidus
  • neurogenic bladder
  • congestive heart failure
  • indwelling catheters
  • urinary tract infection or urinary stones
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280279

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sung Yong Cho, M.D. Seoul National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01280279     History of Changes
Other Study ID Numbers: nocturiaact, nocturiabehavior
Study First Received: January 17, 2011
Last Updated: January 19, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Behavior modification, Behavior therapy, Nocturia, Polyuria, Quality of life

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013