A Pilot Study to Evaluate PureWick for Nocturia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PureWick System.
- Who it may be relevant to
- Registry conditions: Nocturia. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night [Time frame: 3 months]
- Change in average number of nocturnal voids at baseline and at 3 months [Time frame: At baseline and 3 months]
- Change of scores on the N-QoL at baseline and at 3-months [Time frame: At baseline and 3 months]
Secondary outcome measures (2)
- Change in the incidence of urinary tract infection (UTI) at baseline and 3 months [Time frame: At baseline and 3 months]
- Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months [Time frame: At baseline and 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Weill Cornell Medicine — New York
- Multi-Specialty NHPP Syosset — Syosset
Publications
- 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
Identifiers
NCT: NCT05090722 · 21-05023603