PureWick System for Urinary Incontinence
(PUREST-M Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of the PureWick™ Male External Catheter for men experiencing nighttime urinary incontinence. Researchers aim to assess user satisfaction and evaluate the device's safety for home use. Participants will use both the PureWick System (a device for managing urinary incontinence) and the UltraFlex Self-Adhering Male External Catheter in different sequences to compare experiences. Men who currently use diapers or pads at night for urine management may be suitable candidates for this trial. As an unphased trial, this study provides participants the chance to contribute to the understanding and improvement of urinary incontinence solutions.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the study team or your doctor.
What prior data suggests that the PureWick System and UltraFlex Self-Adhering Male External Catheter are safe for use in a home setting?
Research has shown that the PureWick System is safe and effective. One study found it to be a reliable and easy-to-use option for managing urine without invasive procedures. No major safety issues have been reported, although information on possible side effects is limited. Users should avoid using the device with materials that block airflow.
Some users of the UltraFlex Male External Catheter have reported discomfort. However, its silicone construction can help prevent skin irritation. The catheter is designed for comfort and to ensure a steady flow of urine.
Both products manage urinary incontinence without invasive methods, reducing the risk of common problems. Users should follow the guidelines and monitor for any discomfort or irritation.12345Why are researchers excited about this trial?
Researchers are excited about the PureWick System for urinary incontinence because it offers a non-invasive alternative to traditional methods like absorbent pads or catheters. Unlike these standard options, the PureWick System uses an external catheter that wicks urine away from the body, reducing skin irritation and the risk of infections. This innovative approach provides comfort and hygiene without the need for invasive procedures, making it a promising option for those managing urinary incontinence.
What evidence suggests that this trial's treatments could be effective for urinary incontinence?
Research has shown that the PureWick System effectively manages urinary incontinence. In one study, 96.8% of participants used it successfully, indicating ease of use. Another study found that 64% of users preferred PureWick over traditional pads, demonstrating high satisfaction. The system also provides a non-invasive way to manage incontinence and helps reduce skin irritation. In this trial, participants will use both the PureWick System and the UltraFlex catheter, designed specifically for men to offer a comfortable and effective solution for male incontinence. Both PureWick and UltraFlex present promising options for managing urinary incontinence at home, and this trial will compare their effectiveness and user satisfaction.56789
Who Is on the Research Team?
Adrian Wagg
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
Adult males over 18 who use diapers or pads at night for urinary incontinence and are willing to follow study procedures. They must not have conditions that lead to very high urine output, be part of a vulnerable population, have used similar devices recently, or have certain genital issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants use the first assigned urine management device overnight for 7 days
Washout
A 2-day washout period between treatment phases
Treatment Phase 2
Participants use the second assigned urine management device overnight for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PureWick System
- UltraFlex Self-Adhering Male External Catheter
Trial Overview
The trial is evaluating the PureWick™ Male External Catheter against an established catheter brand (UltraFlex) for managing nighttime urinary incontinence in men at home. It focuses on device performance and user satisfaction.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
UltraFlex is used first, followed by crossover to PureWick System
PureWick System used first, followed by crossover to UltraFlex
Find a Clinic Near You
Who Is Running the Clinical Trial?
C. R. Bard
Lead Sponsor
Timothy M. Ring
C. R. Bard
Chief Executive Officer since 2003
Bachelor of Science in Industrial and Labor Relations from Cornell University
Dr. Cimler
C. R. Bard
Chief Medical Officer since 2017
Ph.D. in Pharmacology
Becton, Dickinson and Company
Industry Sponsor
Tom Polen
Becton, Dickinson and Company
Chief Executive Officer since 2020
Bachelor’s degree from Salisbury University, MBA from Johns Hopkins University
Meera Gopalakrishnan
Becton, Dickinson and Company
Chief Medical Officer
Ph.D. in Biomedical Engineering from the University of Memphis
Citations
Safety, Efficacy, and Patient-Reported Outcomes of the ...
The data show that 96.8% (947/978) of placements were completed by the participant in the PureWick group and 91.3% (420/460) for the Hollister FUP group.
2.
jnursinghomeresearch.com
jnursinghomeresearch.com/2768-an-observational-study-of-the-purewick-system-in-women-with-urinary-incontinence-at-home-and-in-the-care-nursing-home-setting.htmlAN OBSERVATIONAL STUDY OF THE PUREWICK™ ...
The overall opinion of PureWick was positive compared with pads, with 64% of care/nursing home users choosing to continue using PureWick beyond ...
Clinical outcomes of female external urine wicking devices as ...
Of 2,580 returned records, utilization rates decreased 14% indwelling CAUTI rates nonsignificantly decreased up to 32% CAUTIs per 1,000 pd ...
Outpatient PureWick™ female external catheter system ...
The PureWick™ female external catheter provides a non-invasive method to manage female urinary incontinence, measure urinary output, and reduce skin ...
An Evaluation of the PureWick™ Male External Catheter ...
This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting.
Safety Information - Purewick
Warnings: Do not use the PureWick™ Female External Catheter with bedpan or any material that does not allow for sufficient airflow.
7.
journals.lww.com
journals.lww.com/fpmrs/fulltext/2025/06000/adverse_events_associated_with_female_external.7.aspxAdverse Events Associated With Female External Urinary...
The PureWick device was developed with the goal of reducing the risk of UTIs that are classically associated with IUCs, as well as skin irritation and ...
8.
purewickathome.com
purewickathome.com/?srsltid=AfmBOoqpuMF7OYnaNykFjUPSXBOr6xIRY9RUfInuCXS1IX03vlQPveBMThe BD PureWick™ System - Official Site
Important Safety Information. Indications: The PureWick™ Flex Female External Catheter is intended for non-invasive urine output management in adult users with ...
Adverse Events Associated With Female External Urinary ...
There is a lack of clinical data evaluating the safety of the PureWick device. Objectives: This study aimed to evaluate adverse events ...
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