This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
NCT ID: NCT06666426
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
171 participants
INTERVENTIONAL
2024-10-31
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Hollister
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.
PureWick
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Becton, Dickinson and Company
INDUSTRY
C. R. Bard
INDUSTRY
Responsible Party
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Locations
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Lakeview Clinical Research
Guntersville, Alabama, United States
New Horizons Clinical Trials
Chandler, Arizona, United States
The Practice of Medicine INC.
Eagle Rock, California, United States
Finlay Medical Research
Greenacres City, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Smith Medical Center
Dunwoody, Georgia, United States
Sonar Clinical Research
Riverdale, Georgia, United States
Leavitt Clinical Research
Idaho Falls, Idaho, United States
Research Integrity
Owensboro, Kentucky, United States
Revive Research Institute
Dearborn Heights, Michigan, United States
Trialfinity Clinical Research Center
Hamilton, New Jersey, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Prime Global Research
The Bronx, New York, United States
MultiSpecialty Clinical Research
Johnson City, Tennessee, United States
Trio Clinical Trials
Houston, Texas, United States
Countries
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Other Identifiers
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UCC-23HC009
Identifier Type: -
Identifier Source: org_study_id
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