Clinical trial NCT05090722: A Pilot Study to Evaluate PureWick for Nocturia
Official title: A Pilot Study to Evaluate PureWick for Nocturia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Nocturia
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Becton, Dickinson and Company
First posted: 2021-10-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night
timeFrame: 3 months
measure: Change in average number of nocturnal voids at baseline and at 3 months
timeFrame: At baseline and 3 months
measure: Change of scores on the N-QoL at baseline and at 3-months
timeFrame: At baseline and 3 months
Secondary outcomes:
measure: Change in the incidence of urinary tract infection (UTI) at baseline and 3 months
timeFrame: At baseline and 3 months
measure: Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months
timeFrame: At baseline and 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Bilal Chughtai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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].
citation: 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.
citation: 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.
citation: 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.