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NCT Number: NCT01280279

Necessity for Repetitive Education of Behavioral Modification

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 20, 2011
Registry last updated
Jan 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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