Trials / Completed
CompletedNCT05710718
PureWick™ France and U.S. At-Home Pilot Study
A Comparative Crossover Study on the Safety, Efficacy, and Patient Quality of Life Comparing PureWick™ System With an Established Comparator in the Home Setting for Incontinence Overnight
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.
Detailed description
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. Approximately 30 female participants from 2 sites will be enrolled into the study. Those meeting eligibility criteria will be treated according to the treatment sequence assigned during randomization. Participants will view the standardized training video for the applicable product at the beginning of each treatment phase and have access to the Information for Use document (IFU) to review during each treatment phase. The total expected duration of subject participation is approximately 10 weeks. Participants will use the device assigned in treatment phase 1 overnight while sleeping for 4 weeks (28 days) before transitioning to the second assigned device in treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 weeks) between treatment phases and a re-screening of eligibility criteria before the second phase. In both treatment phases, participants will independently place and remove the FEC (female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is completed on the first day of the treatment phase. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate. Health Care Providers (HCPs) will visit participants' homes daily to perform a skin assessment and collect urine measurements during the treatment phases. Participants will be withdrawn from the treatment phase if grade 4 is achieved in any category on the Draize skin irritation scale. The secondary objectives are to assess quality of life, tolerability, comfort and ease of use. Quality of life and comfort and ease of use will be measured using self-reported changes in quality of life via the validated Nocturia Quality of Life (N-Qol) tool \& the PROMIS Sleep Disturbance Short-form 4a survey, and subjective evaluation of the therapy via participant survey, respectively. Tolerability will be measured by number of days of actual use of both devices, and discontinuation rate attributed to the device's discomfort or inconvenience.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PureWick™ System | The PureWick™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body. |
| 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. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics. |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2024-08-25
- Completion
- 2024-08-25
- First posted
- 2023-02-02
- Last updated
- 2025-07-16
- Results posted
- 2025-07-16
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05710718. Inclusion in this directory is not an endorsement.