PureWick System for Urinary Incontinence

(PUREST-M Trial)

No longer recruiting at 1 trial location

Overseen By Kirsten Hammitt

Age: 65+

Sex: Male

Trial Phase: Academic

Sponsor: C. R. Bard

Disqualifiers: Bowel incontinence, Urinogenital infections, Urinary retention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness and user satisfaction of the PureWick™ Male External Catheter for home use. The study will also assess the device's safety and collect feedback on the user experience. Participants will follow two sequences: one starting with the PureWick™ and then switching to UltraFlex™, and another beginning with UltraFlex™ before trying PureWick™. Men who use diapers or pads at night for urine management and are willing to try these devices may be suitable for this trial. As an unphased trial, this study provides participants the chance to contribute to the understanding of innovative urine management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that the PureWick™ System is safe for use in a home setting?

Research has shown limited information on the safety of the PureWick™ System, but some problems have been reported and recorded in the U.S. Food and Drug Administration's database. Surveys indicate that many users and caregivers find the system easy to use, suggesting it is generally well-liked. This system manages urine without surgery or inserting anything into the body. These findings may help prospective trial participants understand the safety aspects. ^{1 2 3 4 5}

Why 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 catheters and absorbent products. This system uses an external device to wick urine away from the body, reducing the risk of infections and skin irritation associated with internal catheters. Additionally, it provides more comfort and dignity for patients by minimizing discomfort and maintaining dryness. The innovative approach of the PureWick™ System could greatly improve quality of life for those dealing with urinary incontinence.

What evidence suggests that the PureWick™ System is effective for urinary incontinence?

Research has shown that the PureWick™ System offers a promising way to manage urinary incontinence. One study found it captured urine more effectively than other methods. Another study reported that 64% of users preferred it over traditional pads. The PureWick™ device is non-invasive, meaning it doesn't require insertion into the body, which helps prevent skin irritation. This trial will compare the PureWick™ System with the UltraFlex™ device, with participants experiencing both treatments in different sequences. These findings suggest that PureWick™ could provide an effective and comfortable solution for managing urinary incontinence. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for males who need help managing urine output overnight at home, specifically those dealing with stress urinary incontinence, general urinary incontinence, or bedwetting.

Inclusion Criteria

Willing to comply with all study procedures in this protocol

I am a man aged 65 or older.

I am biologically male.

Exclusion Criteria

Is considered a vulnerable population

Any other condition that, in the opinion of the investigator, would preclude them from participating in the study

I often cannot control my bowel movements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 days

Treatment Phase 1

Participants use the first assigned urine management device overnight for 7 days

7 days

Daily assessments

Washout

A 2-day washout period between treatment phases

2 days

Treatment Phase 2

Participants use the second assigned urine management device overnight for 7 days

7 days

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 days

What Are the Treatments Tested in This Trial?

Interventions

• PureWick™ System

Trial Overview The study is testing the UltraFlex™ Self-Adhering Male External Catheter and PureWick™ System to see how well they work and how satisfied users are with these products when used at home.

How Is the Trial Designed?

Group I: Treatment Sequence 2 Experimental Treatment 2 Interventions

UltraFlex™ is used first, followed by cross-over to PureWick™ System

Group II: Treatment Sequence 1 Experimental Treatment 2 Interventions

PureWick™ System is used first, followed by cross-over to UltraFlex™

Who Is Running the Clinical Trial?

C. R. Bard

Lead Sponsor

Trials

109

Recruited

40,200+

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

Trials

80

Recruited

92,000+

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

Published Research Related to This Trial

The developed sensor and electronics system effectively monitors urine leakage from continence pads, providing real-time feedback to users by vibrating when a leak is detected.

This innovative technology aims to enhance the quality of life for individuals with urinary incontinence, particularly benefiting those using continence pads in community settings or care homes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary incontinence: a vibration alert system for detecting pad overflow. Fernandes, B., Gaydecki, P., Jowitt, F., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11518674/

Clinical outcomes of female external urine wicking devices as ... Overall, FEUWDs nonsignificantly reduced indwelling CAUTI rates, though reductions were significant among studies describing FEUWD implementation protocols.

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.html

AN 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772973723001406

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 ...

4. ics.org ics.org/2024/abstract/645

ICS 2024 Abstract #645 A comparative study of the efficacy ... This single blind cross over study of the efficiency of urine capture showed a statistically significantly superior performance of the Purewick ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06850259

NCT06850259 | This Study Will Collect Clinical and Patient ... This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting.

6. purewickathome.ca purewickathome.ca/support-resources/safety-information/

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.aspx

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 associated with the ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39945631/

Adverse Events Associated With Female External Urinary ... There are adverse events associated with the PureWick external urinary collection device in reports from the US Food and Drug Administration database.

9. purewickathome.com purewickathome.com/?srsltid=AfmBOoo8ciiw2xml0mjhQ4fRNwkNZsoZ7g6AEjTwS3FmpCzbaPaCzr9x

The BD PureWick™ System - Official Site Based on a survey of 324 respondents, 93% of caregivers and 84% of users agree the PureWick™ System is easy to set up. Respondents used the PureWick™ Urine ...

10. bd.com bd.com/en-us/products-and-solutions/products/product-families/purewick-female-external-catheter

PureWick Female External Catheter (FEC) The PureWick™ Male External Catheter is intended for non-invasive urine output management, such as urinary incontinence, in users with male anatomy.