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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
171
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.
Lakeview Clinical Research
Guntersville, Alabama, United States
New Horizons Clinical Trials
Chandler, Arizona, United States
The Practice of Medicine INC.
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)
Time frame: 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.
Time frame: From enrollment to the end of treatment at 4 weeks
Participant Device Tolerance
Number of days of actual device use over the expected treatment duration.
Time frame: From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Comfort
Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
Time frame: From enrollment to the end of treatment at 4 weeks
Participant Device Experience - Ease of Use
Overall ease of use on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
Time frame: From enrollment to the end of treatment at 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 5 more locations