A Pilot Study to Evaluate PureWick for Nocturia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: The PureWick Urine Collection System 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. |
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.
Other Names:
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Outcome Measures
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 [3 months]
The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night will be calculated via binomial proportions and an exact (Clopper-Pearson) 95% confidence interval will be computed to assess the precision of the obtained estimate.
- Change in average number of nocturnal voids at baseline and at 3 months [At baseline and 3 months]
The paired t-test or Wilcoxon signed-rank test will be used, as appropriate, to compare the average number of nocturnal voids between baseline and at 3 months.
- Change of scores on the N-QoL at baseline and at 3-months [At baseline and 3 months]
N-QoL (Nocturia quality of life) score is determined by the n-qol short form. The ICIQ-Nqol is a patient-completed questionnaire evaluating quality of life (QoL) in patients with nocturia for use in research and clinical practice across the world. The ICIQ-Nqol is the N-QoL adapted for use within the ICIQ structure and provides a detailed and robust measure to assess the impact of nocturia on quality of life with particular reference to the effects on patient' lives of Nocturia and can be used as an outcome measure to assess impact of different treatment modalities. 0-52 overall score with greater values indicating increased impact on quality of life Bother scale not incorporated into overall score but indicate impact of symptoms overall for the patient. Similar analyses to paired t-test or Wilcoxon signed-rank test will be performed to compare scores on the N-QoL, an self-reported sleep quality between baseline and at 3-months.
Secondary Outcome Measures
- Change in the incidence of urinary tract infection (UTI) at baseline and 3 months [At baseline and 3 months]
McNemar's chi-square test will be used to compare the incidence of UTI between baseline and at 3 months.
- Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months [At baseline and 3 months]
McNemar's chi-square test will be used to compare pressure ulcers/skin breakdown between baseline and at 3 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged 50 years or older.
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Experiences 2 or more voids per night as assessed on a 3-day bladder diary.
Exclusion Criteria:
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Compromised skin integrity in the perineal area (e.g., ulcers, open wounds, etc.).
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Neurological impairment or psychiatric disorder preventing proper understanding of consent.
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Unable to operate the PureWick system.
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Unable to complete required questionnaires and diaries.
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Investigator deems subject as unsuitable for enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medicine | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- Becton, Dickinson and Company
Investigators
- Principal Investigator: Bilal Chughtai, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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].
- 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. Review.
- 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.
- 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.
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