Necessity for Repetitive Education of Behavioral Modification

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment
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

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	104 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Short-term Effects of Systematized Behavioral Modification Program (SBMP) for Nocturia: A Prospective Study
Study Start Date :	May 2009
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	January 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. decrease of nocturnal urine volume [ Time Frame: 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 Outcome Measures :

1. improvement of symptoms and quality of life [ Time Frame: 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 Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT01280279 History of Changes
Other Study ID Numbers:	nocturiaact; nocturiabehavior
First Posted:	January 20, 2011
Last Update Posted:	January 20, 2011
Last Verified:	January 2011

Keywords provided by Seoul National University Hospital:

Behavior modification, Behavior therapy, Nocturia, Polyuria, Quality of life

Additional relevant MeSH terms:

Nocturia; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms