This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting. (PUREST)

A Randomized, Controlled Trial on the Safety, Efficacy, and Patient Reported Experience Comparing PureWick™ System With an Established Comparator Overnight in the Home Setting (PUREST)

This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence (UI); Adult Nocturnal Enuresis
• Intervention / Treatment: Device: Hollister Female Urinary Pouch External Collection Device; Device: PureWick System

Detailed Description

Approximately 150 women with nighttime urinary incontinence will take part in this prospective, open-label, randomized trial. Participants will use one of two different study devices during the study to manage urine output at night: PureWick™ System or the Hollister® Female Urinary Pouch External Collection Device. Participant device assignment will be random. Participants will use the assigned urine management device overnight while sleeping and will be followed for approximately 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Guntersville, Alabama, United States, 35976
      • Lakeview Clinical Research
  • Arizona
    • Chandler, Arizona, United States, 85224
      • New Horizons Clinical Trials
  • California
    • Eagle Rock, California, United States, 90041
      • The Practice of Medicine INC.
  • Florida
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research
    • Miami, Florida, United States, 33126
      • Finlay Medical Research
  • Georgia
    • Dunwoody, Georgia, United States, 30338
      • Smith Medical Center
    • Riverdale, Georgia, United States, 30274
      • Sonar Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity
  • Michigan
    • Dearborn Heights, Michigan, United States, 48127
      • Revive Research Institute
  • New Jersey
    • Hamilton, New Jersey, United States, 08619
      • Trialfinity Clinical Research Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Bronx, New York, United States, 10456
      • Prime Global Research
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • MultiSpecialty Clinical Research
  • Texas
    • Houston, Texas, United States, 77008
      • Trio Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
2. Currently use diapers or equivalent at night for urine output management.
3. Willing to comply with all study procedures in this CIP.
4. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Has frequent episodes of bowel incontinence without a fecal management system in place; or
2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
3. Has urinary tract, vaginal or other chronic infections, active genital herpes; or
4. Has urinary retention; or
5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
7. Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
8. Is known to be pregnant at time of enrollment (for women of childbearing age); or
9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hollister	Device: Hollister Female Urinary Pouch External Collection Device; The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence.
Experimental: PureWick	Device: PureWick System; The PureWick System consists of the PureWick Urine Collection System used with the PureWick Flex Female External Catheter, which are intended for non-invasive urine output management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the PureWick System in the home setting	Daily capture rate (captured as % of urine captured by device and collected in canister, measured by weight)	From enrollment to the end of treatment at 4 weeks
Safety of the PureWick System in the home setting	Daily skin irritation score using the 5-point Draize dermal irritation scoring system ranging from 0 to 4 with higher scores indicating greater irritation.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Device Tolerance	Number of days of actual device use over the expected treatment duration.	From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Comfort	Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.	From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Ease of Use	Overall ease of use on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.	From enrollment to the end of treatment at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal Incontinence related Quality of Life	Nocturia Quality of Life (N-QOL) score collected at baseline and every 2 weeks during treatment with higher scores indicating better QoL. The NQoL contains 12 scored items each scored from 0 to 4. All item scores are computed into a total score ranging from 0-100 where 0 is the worst QoL and 100 is the best QoL.	From enrollment to the end of treatment at 4 weeks
Participant Sleep Quality	PROMIS Sleep Disturbance Short Form 4a score collected at baseline and every 7 days during treatment with higher scores indicating greater sleep disturbance. The PROMIS Sleep Disturbance 4a contains 4 scored items each scored from 1 to 5. All item raw scores are computed into a total score where higher scores indicate a worse outcome.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; females; sleep disturbance; PROMIS; BD; nighttime urinary incontinence; NQoL; Purewick; Hollister; PureWick Flex Female External Catheter; PureWick Urine Collection System; The Hollister Female Urinary Pouch; Becton, Dickinson and Company
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis
• Other Study ID Numbers: UCC-23HC009

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
• product manufactured in and exported from the U.S.: No