This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
- Conditions
- Adult Nocturnal EnuresisUrinary Incontinence (UI)
- Registration Number
- NCT06666426
- Lead Sponsor
- C. R. Bard
- 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.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety of the PureWick System in the home setting From enrollment to the end of treatment at 4 weeks Daily skin irritation score using the 5-point Draize dermal irritation scoring system ranging from 0 to 4 with higher scores indicating greater irritation.
Performance of the PureWick System in the home setting From enrollment to the end of treatment at 4 weeks Daily capture rate (captured as % of urine captured by device and collected in canister, measured by weight)
- Secondary Outcome Measures
Name Time Method Participant Device Experience - Ease of Use From enrollment to the end of treatment at 4 weeks Overall ease of use on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
Participant Device Tolerance From enrollment to the end of treatment at 4 weeks Number of days of actual device use over the expected treatment duration.
Participant Device Experience - Comfort From enrollment to the end of treatment at 4 weeks Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
Trial Locations
- Locations (14)
New Horizons Clinical Trials
🇺🇸Chandler, Arizona, United States
The Practice of Medicine INC.
🇺🇸Eagle Rock, California, United States
Smith Medical Center
🇺🇸Dunwoody, Georgia, United States
Sonar Clinical Research
🇺🇸Riverdale, Georgia, United States
Leavitt Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
MultiSpecialty Clinical Research
🇺🇸Johnson City, Tennessee, United States
Lakeview Clinical Research
🇺🇸Guntersville, Alabama, United States
Finlay Medical Research
🇺🇸Miami, Florida, 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
Prime Global Research
🇺🇸Bronx, New York, United States
Trio Clinical Trials
🇺🇸Houston, Texas, United States