A Pilot Study to Evaluate PureWick for Nocturia

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.

Study Overview

• Status: Suspended
• Conditions: Nocturia
• Intervention / Treatment: Device: PureWick System

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sagar Shah, RC; Phone Number: 6469629395; Email: sas4051@med.cornell.edu
• Study Contact Backup: Name: Rabia Bukhari, RN; Phone Number: 6469629395; Email: rnb4002@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: PureWick Urine Collection System device; PWF030F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night	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.	3 months
Change in average number of nocturnal voids at baseline and at 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.	At baseline and 3 months
Change of scores on the N-QoL at baseline and at 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.	At baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the incidence of urinary tract infection (UTI) 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.	At baseline and 3 months
Change in the incidence of pressure ulcers/skin breakdown 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.	At baseline and 3 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Becton, Dickinson and Company
• Investigators: Principal Investigator: Bilal Chughtai, MD, Weill Medical College of Cornell University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia
• Other Study ID Numbers: 21-05023603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes