PureWick System for Urinary Incontinence

(PUREST-M Trial)

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

15 Participants Needed

Trial Summary

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 data supports the effectiveness of the PureWick System treatment for urinary incontinence?

The PureWick System is a non-invasive urine collection device that may help reduce catheter-associated urinary tract infections (CAUTIs), maintain skin health, and accurately measure urine output in incontinent women, potentially avoiding extra healthcare costs. ^{1 2 3 4 5}

Is the PureWick System safe for managing urinary incontinence?

The PureWick System is a non-invasive urine collection device that may help reduce catheter-associated urinary tract infections (CAUTIs) and maintain skin integrity, suggesting it is generally safe for use in incontinent women. ^{1 2 5 6 7}

How does the PureWick System treatment for urinary incontinence differ from other treatments?

The PureWick System is unique because it is a non-invasive treatment that uses a low-pressure suction to draw urine away from the body into a collection canister, reducing the risk of infections associated with traditional catheters. This system helps maintain skin health and accurately measures urine output without the need for invasive procedures. ^{2 3 5 8 9}

What is the purpose of this trial?

This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term results of the FemSoft urethral insert for the management of female stress urinary incontinence. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

How I Do It: PureWick female external catheter: a non-invasive urine management system for incontinent women. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A new pelvic muscle trainer for the treatment of urinary incontinence. [2016]

4. England pubmed.ncbi.nlm.nih.gov

The Clear Advantage urinary incontinence sheath for men. [2004]

5. England pubmed.ncbi.nlm.nih.gov

A single institution pre-/post-comparison after introduction of an external urinary collection device for female medical patients. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the NEAT expandable tip continence device. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Patient and caretaker satisfaction with the PureWick system. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Urinary incontinence: a vibration alert system for detecting pad overflow. [2012]