PureWick System for Urinary Incontinence

(PUREST Trial)

No longer recruiting at 16 trial locations

Overseen By Kirsten Hammitt

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: C. R. Bard

Disqualifiers: Bowel incontinence, Heavy menstruation, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of the PureWick System, a device for managing urinary incontinence, for women using it at home. The researchers aim to determine if this device improves comfort and quality of life compared to traditional methods like diapers. Women who currently use diapers at night to manage urine leaks may find this trial suitable.

As an unphased trial, this study provides a unique opportunity to explore innovative solutions for enhancing daily life.

Do I need to stop my current medications to join the trial?

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 clinical data on the safety of the PureWick System, an external device for urine collection. The US Food and Drug Administration has reported some problems with its use. Despite these reports, the device is on the market, indicating it meets certain safety standards.

A survey found that most users and caregivers consider the PureWick System easy to set up. This ease of use suggests it is safe and user-friendly. However, warnings include avoiding use with materials that block airflow.

In summary, while some issues have been reported, the PureWick System is in use, indicating it is generally safe for its intended purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for urinary incontinence that often involve medications or invasive procedures, the PureWick System offers a non-invasive alternative. This innovative system uses an external catheter to wick urine away from the body, reducing the risks of infection and skin irritation associated with prolonged exposure to moisture. Researchers are excited about the PureWick System because it provides a simple, comfortable solution for managing urinary incontinence, especially for patients who may not tolerate other interventions well.

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

Research has shown that the PureWick System, which participants in this trial may receive, is a promising way to manage urinary incontinence. Studies have found that it offers a non-invasive method to help women manage this condition, allowing for easy measurement of urine output and reducing skin problems. This trial will compare the PureWick System to the Hollister Female Urinary Pouch External Collection Device. Previous research indicates that the PureWick System was significantly better at collecting urine than other methods. Additionally, an observational study found that 64% of users in care or nursing homes preferred PureWick over traditional pads. While it might not greatly lower infection rates on its own, its overall effectiveness and positive reception in managing incontinence are encouraging. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This clinical trial is for individuals who need help managing urine output overnight at home, specifically those experiencing urinary incontinence or bedwetting. The study seeks participants to share their experiences before and after using the PureWick System.

Inclusion Criteria

Willing to comply with all study procedures in this CIP

Provision of signed and dated informed consent form

I use diapers or similar products at night for bladder control.

Exclusion Criteria

Has frequent episodes of bowel incontinence without a fecal management system in place

I experience heavy periods and cannot use tampons or menstrual cups.

I have ongoing infections, including in the urinary tract or genital herpes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the assigned urine management device overnight while sleeping

4 weeks

Weekly assessments (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hollister Female Urinary Pouch External Collection Device
• PureWick System

Trial Overview The trial is evaluating the performance and user experience of the PureWick System compared to a Hollister Female Urinary Pouch. It's an observational study focusing on how well these devices work and their impact on quality of life.

How Is the Trial Designed?

Group I: PureWick Experimental Treatment 1 Intervention

Group II: Hollister Active Control 1 Intervention

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

Following the 2011 FDA warning about adverse events related to transvaginal mesh for pelvic organ prolapse, the use of mesh slings for stress urinary incontinence (SUI) in New York decreased by 43% from 2011 to 2015, indicating a significant impact of regulatory notifications on clinical practice.

The decline in mesh sling usage was primarily observed among non-FPMRS (Female Pelvic Medicine and Reconstructive Surgery) providers, while FPMRS-certified physicians continued to perform a higher proportion of sling procedures, suggesting that specialized training may influence the adoption and safety perceptions of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends of Mesh Utilization for Stress Urinary Incontinence Before and After the 2011 Food and Drug Administration Notification Between FPMRS-Certified and Non-FPMRS-Certified Physicians: A Statewide All-Payer Database Analysis. Siegal, AR., Huang, Z., Gross, MD., et al.[2022]

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.