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NCT05710718 · ClinicalTrials.gov registry record · NA
PureWick™ France and U.S. At-Home Pilot Study
A NA study, sponsored by C. R. Bard.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT05710718: Completed NA study, sponsored by C. R. Bard.
NCT05710718 is a NA study that has completed, run by C. R. Bard. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05710718, a NA study, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calcula
Interventions
- DEVICE PureWick™ System
- DEVICE Hollister® Female Urinary Pouch External Collection Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2024-08-25 |
| Phase | NA |
What the finished NCT05710718 record still lists
NCT05710718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which PureWick™ System is the first listed.
NCT05710718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05710718 about?
NCT05710718 is a clinical study titled "PureWick™ France and U.S. At-Home Pilot Study". 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 Ext...
What is the current status of trial NCT05710718?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2023-10-31. Estimated completion is 2024-08-25.
What interventions are being tested in trial NCT05710718?
The interventions under investigation include: PureWick™ System (DEVICE), Hollister® Female Urinary Pouch External Collection Device (DEVICE).
Who is sponsoring clinical trial NCT05710718?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05710718's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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