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Urinary Collection Devices for Bedwetting
N/A
Waitlist Available
Research Sponsored by C. R. Bard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 29 days during each treatment phase
Awards & highlights
No Placebo-Only Group
Summary
This trial will study two devices to help women with urinary incontinence, assessing safety and effectiveness. Daily urine capture rate will be measured for 10 weeks.
Who is the study for?
This trial is for adult women over 18 with urinary incontinence who use diapers at night. Participants must be willing to follow the study procedures and provide consent. It's not suitable for those with frequent bowel incontinence without management, heavy menstruation unable to use tampons or cups, active infections, urinary retention, combative behavior, genital wounds or irritations, certain neurological conditions, pregnancy or any condition that may affect self-reporting.
What is being tested?
The study compares two devices: PureWick™ System and Hollister® Female Urinary Pouch External Collection Device for managing nighttime urinary incontinence. Women will be randomly assigned to a sequence of using both devices across approximately 10 weeks. The focus is on safety (skin injury) assessed by the Draize Scale and efficacy measured by urine capture rate.
What are the potential side effects?
Potential side effects include skin injuries which will be monitored using the Draize Scale. Since this trial involves external collection devices rather than medications, traditional drug-related side effects are not expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily use of for 29 days during each treatment phase and one survey collected at the end of each treatment phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily use of for 29 days during each treatment phase and one survey collected at the end of each treatment phase
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Daily skin irritation score using the Draize Scale
Daily urine capture rate (percentage)
Secondary study objectives
Nocturia Quality of Life (N-QOL) score
Participant's comfort level associated with device/treatment
Participant's opinion of ease of device/treament
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PureWick™ SystemExperimental Treatment1 Intervention
The PureWick™ System includes the PureWick™ Female External Catheter and the PureWick™ Urine Collection System. The PureWick™ Female External Catheter (PureWick™ FEC) is marketed in both the United States and Europe. In the U.S. PureWick™ FEC is a Class I, 510(k) exempt device. In Europe, the PureWick™ FEC is a Class I, Conformitè Europëenne (CE) marked, non-sterile device.
Group II: Hollister® Female Urinary Pouch External Collection DeviceActive Control1 Intervention
The urinary collection pouch with a skin barrier is suitable for non-ambulatory females with urinary incontinence.
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Who is running the clinical trial?
C. R. BardLead Sponsor
106 Previous Clinical Trials
39,927 Total Patients Enrolled