This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
Launched by C. R. BARD · Oct 29, 2024
Trial Information
Current as of June 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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.
Gender
FEMALE
Eligibility criteria
- 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.
About C. R. Bard
C.R. Bard, a leading global provider of innovative medical technologies, specializes in developing and manufacturing a wide range of products for vascular, urology, and surgical specialties. With a strong commitment to improving patient outcomes, the company focuses on advancing healthcare through research and clinical trials that support the efficacy and safety of its devices. C.R. Bard is dedicated to fostering collaboration with healthcare professionals and regulatory bodies to ensure that its solutions meet the highest standards of quality and effectiveness, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Albuquerque, New Mexico, United States
Owensboro, Kentucky, United States
Miami, Florida, United States
Chandler, Arizona, United States
Greenacres City, Florida, United States
Idaho Falls, Idaho, United States
Guntersville, Alabama, United States
Bronx, New York, United States
Houston, Texas, United States
Greenacres, Florida, United States
Dearborn Heights, Michigan, United States
Hamilton, New Jersey, United States
Eagle Rock, California, United States
Dunwoody, Georgia, United States
Riverdale, Georgia, United States
Johnson City, Tennessee, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported