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)
1 other identifier
interventional
171
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2024
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 24, 2025
July 1, 2025
8 months
October 28, 2024
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Participant Device Tolerance
From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Comfort
From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Ease of Use
From enrollment to the end of treatment at 4 weeks
Other Outcomes (2)
Nocturnal Incontinence related Quality of Life
From enrollment to the end of treatment at 4 weeks
Participant Sleep Quality
From enrollment to the end of treatment at 4 weeks
Study Arms (2)
Hollister
ACTIVE COMPARATORPureWick
EXPERIMENTALInterventions
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.
The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence.
Eligibility Criteria
You may qualify if:
- Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
- Currently use diapers or equivalent at night for urine output management.
- Willing to comply with all study procedures in this CIP.
- Provision of signed and dated informed consent form.
You may not qualify if:
- Has frequent episodes of bowel incontinence without a fecal management system in place; or
- Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
- Has urinary tract, vaginal or other chronic infections, active genital herpes; or
- Has urinary retention; or
- Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
- Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
- 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
- Is known to be pregnant at time of enrollment (for women of childbearing age); or
- Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
- Becton, Dickinson and Companycollaborator
Study Sites (15)
Lakeview Clinical Research
Guntersville, Alabama, 35976, United States
New Horizons Clinical Trials
Chandler, Arizona, 85224, United States
The Practice of Medicine INC.
Eagle Rock, California, 90041, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
Finlay Medical Research
Miami, Florida, 33126, United States
Smith Medical Center
Dunwoody, Georgia, 30338, United States
Sonar Clinical Research
Riverdale, Georgia, 30274, United States
Leavitt Clinical Research
Idaho Falls, Idaho, 83404, United States
Research Integrity
Owensboro, Kentucky, 42303, United States
Revive Research Institute
Dearborn Heights, Michigan, 48127, United States
Trialfinity Clinical Research Center
Hamilton, New Jersey, 08619, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Prime Global Research
The Bronx, New York, 10456, United States
MultiSpecialty Clinical Research
Johnson City, Tennessee, 37604, United States
Trio Clinical Trials
Houston, Texas, 77008, United States
Related Publications (1)
Medina JC, Fakih M, Khalsa S, Redmond D, Kennelly MJ. Safety, Efficacy, and Patient-Reported Outcomes of the PureWick System Versus Comparator for Nocturnal Urinary Incontinence in the Home Setting: Results of a Randomized Trial. J Clin Med. 2025 Dec 9;14(24):8699. doi: 10.3390/jcm14248699.
PMID: 41464602DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2024
First Posted
October 30, 2024
Study Start
October 31, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share