Necessity for Repetitive Education of Behavioral Modification

NCT01280279 — Completed, 104 participants, Seoul National University Hospital

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Short-term Effects of Systematized Behavioral Modification Program (SBMP) for Nocturia: A Prospective Study

RegistryNCT01280279
StatusCompleted
Study typeObservational
Enrollment104 (Actual)
SponsorSeoul National University Hospital (Other)
ConditionsPatients 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)
Interventionseducation for behavioral modification (Other)
Datesstart 2009-05-01, primary completion 2010-03-01, completion 2011-01-01, first posted 2011-01-20, last updated 2011-01-20
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for 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) All trials of education for behavioral modification

-Summary

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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
group with nocturnal polyuria and nocturiaOther: education for behavioral modificationPatients 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)
  • education for behavioral modification (Other): a systematized 30-minutes education program for behavioral modification (SBMP) by watching videos and discussion with a specialized continence nurse practitioner.

+Outcome measures

Primary outcomes

  • decrease of nocturnal urine volume [1 month after education]: 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 outcomes

  • improvement of symptoms and quality of life [1 month after education]: 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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

FacilityCityCountryStatus
Seoul National University HospitalSeoulSouth Korea

+Investigators