Necessity for Repetitive Education of Behavioral Modification

Completed

• Conditions: 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)
• Interventions: Other: education for behavioral modification

• Registration Number: NCT01280279
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study Start: 2009-05
• Primary Completion: 2010-03
• Status Verified: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-01-17
• Study First Submitted QC: 2011-01-19
• Last Update Submitted: 2011-01-19
• Study First Posted: 2011-01-20
• Last Update Posted: 2011-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group with nocturnal polyuria and nocturia	education for behavioral modification	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of