This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
Completed · Not applicable
Conditions studied: Adult Nocturnal Enuresis, Urinary Incontinence (UI)
In brief
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.
Key facts
- Study ID
- NCT06666426
- Run by
- C. R. Bard
- People needed
- 171
- Starts
- 2024-10-31
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2025-07-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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