At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating PureWick™ System and Hollister® Female Urinary Pouch External Collection Device for Nocturnal Enuresis. Completed, enrolled 17 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.