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

January 17, 2011
January 19, 2011
May 2009
March 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01280279 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Necessity for Repetitive Education of Behavioral Modification
Short-term Effects of Systematized Behavioral Modification Program (SBMP) for Nocturia: A Prospective Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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)

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
a systematized 30-minutes education program for behavioral modification (SBMP) by watching videos and discussion with a specialized continence nurse practitioner.
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)
Intervention: Other: education for behavioral modification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
January 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01280279
nocturiaact, nocturiabehavior
Yes
Not Provided
Seoul National University Hospital
Not Provided
Principal Investigator: Sung Yong Cho, M.D. Seoul National University Hospital
Seoul National University Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP