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Идёт набор NCT05090722

A Pilot Study to Evaluate PureWick for Nocturia

Без фазы С лечением Nocturia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PureWick System.
Кому может быть актуально
Состояния в реестре: Nocturia. Базовые параметры: от 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a single-center prospective pilot study of PureWick used as a management for nocturia and reduction of nighttime falls associated with going to the bathroom. Subjects are followed up to 3 months after the intervention. As a pilot study, it is expected that a 3-month follow-up will adequately capture urinary and sleep outcomes data and any adverse events related or unrelated to the study device.

Подробное описание

Nocturia is a highly prevalent condition among older adults, significantly affecting the quality of life as well as putting them at an increased risk of falls and fractures. In those 65 and older, accidental falls are identified as the leading cause of injury and death. The chance of falling increases from 30% to 50% with age greater than 85 years.

A study identified that in 1508 ambulatory men and women, nighttime urination of 2 times at night is associated with increased risk of falls (OR=1.84, 95% CI 1.05-3.22), with significantly higher risks when it increased to 3 or more times at night (OR=2.15, CI 95% -1.04-4.44). Incontinence management that reduces the need to get out of bed will lead to reduced risk of falls and unintentional injury fatalities.

The PureWick Urine Collection System is intended for non-invasive urine output management. It pulls urine through tubing that is connected to a collection canister for proper disposal. It is designed to be used by patients, caregivers, or healthcare professionals in both home environments and professional care facilities.

The PureWick System allows individuals to void while still in bed, demonstrating the potential to reduce the risks of falls associated with nighttime voids in men and women with nocturia. We hypothesize that this will also improve sleep quality and overall quality of life.

Вмешательства

  • Устройство PureWick System
    The PureWick system consists of the external catheter, collection tubing, and collection canister with lid. It operates via a power cord that is plugged into the device outlet and the A/C power outlet.

Первичные конечные точки

  • The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night [Срок оценки: 3 months]
  • Change in average number of nocturnal voids at baseline and at 3 months [Срок оценки: At baseline and 3 months]
  • Change of scores on the N-QoL at baseline and at 3-months [Срок оценки: At baseline and 3 months]
Вторичные конечные точки (2)
  • Change in the incidence of urinary tract infection (UTI) at baseline and 3 months [Срок оценки: At baseline and 3 months]
  • Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months [Срок оценки: At baseline and 3 months]

Критерии участия

Критерии включения

  • Women aged 50 years or older.
  • Experiences 2 or more voids per night as assessed on a 3-day bladder diary.

Критерии исключения

  • Compromised skin integrity in the perineal area (e.g., ulcers, open wounds, etc.).
  • Neurological impairment or psychiatric disorder preventing proper understanding of consent.
  • Unable to operate the PureWick system.
  • Unable to complete required questionnaires and diaries.
  • Investigator deems subject as unsuitable for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Weill Cornell Medicine — New York
  • Multi-Specialty NHPP Syosset — Syosset

Публикации

  • Chiarelli PE, Mackenzie LA, Osmotherly PG. Urinary incontinence is associated with an increase in falls: a systematic review. Aust J Physiother. 2009;55(2):89-95. doi: 10.1016/s0004-9514(09)70038-8. PMID 19463079
  • Centers for Disease Control and Prevention, N.C.f.I.P.a.C. Web-based Injury Statistics Query and Reporting System (WISQARS). December 7, 2014].
  • Medical Advisory Secretariat. Prevention of falls and fall-related injuries in community-dwelling seniors: an evidence-based analysis. Ont Health Technol Assess Ser. 2008;8(2):1-78. Epub 2008 Oct 1. PMID 23074507
  • Hunter KF, Voaklander D, Hsu ZY, Moore KN. Lower urinary tract symptoms and falls risk among older women receiving home support: a prospective cohort study. BMC Geriatr. 2013 May 15;13:46. doi: 10.1186/1471-2318-13-46. PMID 23672343
  • Beeson T, Davis C. Urinary Management With an External Female Collection Device. J Wound Ostomy Continence Nurs. 2018 Mar/Apr;45(2):187-189. doi: 10.1097/WON.0000000000000417. PMID 29394218

Идентификаторы

NCT: NCT05090722 · 21-05023603

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗