Trials / Completed
CompletedNCT06666426
This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
A Randomized, Controlled Trial on the Safety, Efficacy, and Patient Reported Experience Comparing PureWick™ System With an Established Comparator Overnight in the Home Setting (PUREST)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 171 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| DEVICE | 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. |
Timeline
- Start date
- 2024-10-31
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2024-10-30
- Last updated
- 2025-07-24
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06666426. Inclusion in this directory is not an endorsement.