PureWick System for Urinary Incontinence

(PUREST Trial)

Recruiting at 15 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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the PureWick System for Urinary Incontinence treatment?

The research does not directly address the PureWick System, but studies on pelvic floor muscle training (PFMT) show that women with urinary incontinence often report improvement when they receive regular supervision from health professionals. This suggests that consistent support and guidance can enhance the effectiveness of treatments for urinary incontinence. ^{1 2 3 4 5}

Is the PureWick System safe for managing urinary incontinence?

The PureWick System is a non-invasive device that may help reduce the risk of catheter-associated urinary tract infections (CAUTIs) and maintain skin health in incontinent women. While specific safety data for the PureWick System is limited, it is generally considered a safer alternative to traditional catheters, which carry a higher risk of infections. ^{6 7 8 9 10}

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 low-pressure suction to wick urine away from the body into a collection canister, reducing the risk of infections associated with traditional catheters and helping maintain skin health. ^{3 9 10 11 12}

What is the purpose of this trial?

This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.

Eligibility Criteria

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

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

Willing to comply with all study procedures in this CIP

Provision of signed and dated informed consent form

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women: an abridged Cochrane systematic review. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Multifaceted self-management interventions for older women with urinary incontinence: a systematic review and narrative synthesis. [2020]

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

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

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

The Adherence of Home Pelvic Floor Muscles Training Using a Mobile Device Application for Women With Urinary Incontinence: A Randomized Controlled Trial. [2021]

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

Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

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

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

8. United States 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. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

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

10. 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]

11. Canada pubmed.ncbi.nlm.nih.gov

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

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

Self-powered wireless disposable sensor for welfare application. [2020]