Necessity for Repetitive Education of Behavioral Modification

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) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280279
• Other study ID #: nocturiaact
• Secondary ID: nocturiabehavior
• Status: Completed
• Phase: N/A
• First received: January 17, 2011
• Last updated: January 19, 2011
• Start date: May 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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)

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease of nocturnal urine volume	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.	1 month after education	No
Secondary	improvement of symptoms and quality of life	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.	1 month after education	No