Urinary Collection Devices for Bedwetting

No longer recruiting at 4 trial locations

Overseen By Kirsten Hammitt

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: C. R. Bard

Disqualifiers: Bowel incontinence, Infections, Neurological, 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 tests two devices designed to help women manage bedwetting due to urinary incontinence. Researchers aim to determine which device is safer for the skin and more effective at collecting urine overnight. Women who regularly use diapers at night for urinary incontinence may be suitable for this study. Participants will use each device for four weeks to help identify which one performs best. As an unphased trial, this study allows participants to contribute to research that could enhance the quality of life for women facing similar challenges.

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

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

What prior data suggests that these urinary collection devices are safe for women with urinary incontinence?

Research shows that the Hollister® Female Urinary Pouch is designed for women with limited mobility who need assistance managing urine flow. It features a SoftFlex™ skin barrier that can be trimmed for a comfortable and personalized fit, likely enhancing user comfort.

For the PureWick™ System, although detailed safety information is limited, it is generally considered safer than traditional catheters, which often carry a higher risk of infections. It is important to avoid using the PureWick™ with materials that block airflow, as this could cause discomfort.

Both devices have been used outside of clinical trials, suggesting they are safe for public use. However, those considering joining a trial should discuss any potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these urinary collection devices for bedwetting because they offer non-invasive, external solutions compared to traditional options like absorbent pads or medication. The PureWick™ System uses a gentle suction technique to wick urine away from the body, which can significantly reduce skin irritation and improve comfort. The Hollister® Female Urinary Pouch offers a discreet and secure way to collect urine externally, potentially enhancing convenience and dignity for users. These innovative methods provide promising alternatives that could improve quality of life for those experiencing bedwetting.

What evidence suggests that these urinary collection devices are effective for bedwetting?

This trial will compare the effectiveness of two urinary collection devices for managing bedwetting. Research has shown that the PureWick™ System, which participants in this trial may use, effectively manages urinary incontinence in women. In one study, 64% of users in care settings preferred it over traditional pads, finding it more satisfying and convenient, suggesting it manages urine better.

The Hollister® Female Urinary Pouch, another device tested in this trial, is designed to collect urine for those with incontinence. Its custom-fit feature aims to improve comfort and effectiveness in managing urine. Both devices offer non-invasive ways to handle nighttime bedwetting, focusing on capturing urine efficiently and safely. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adult women over 18 with urinary incontinence who use diapers at night. Participants must be willing to follow the study procedures and provide consent. It's not suitable for those with frequent bowel incontinence without management, heavy menstruation unable to use tampons or cups, active infections, urinary retention, combative behavior, genital wounds or irritations, certain neurological conditions, pregnancy or any condition that may affect self-reporting.

Inclusion Criteria

Willing to comply with all study procedures in this protocol

I am a woman over 18 and have agreed to participate.

Provision of signed and dated informed consent form

Exclusion Criteria

Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator

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

Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants use the first assigned device (either PureWick™ System or Hollister Female Urinary Pouch) overnight for 4 weeks

4 weeks

Daily home visits by HCPs for skin assessment and urine measurement

Washout

A washout period between treatment phases to ensure no carryover effects

2-4 weeks

Treatment Phase 2

Participants switch to the second assigned device and use it overnight for 4 weeks

4 weeks

Daily home visits by HCPs for skin assessment and urine measurement

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 study compares two devices: PureWick™ System and Hollister® Female Urinary Pouch External Collection Device for managing nighttime urinary incontinence. Women will be randomly assigned to a sequence of using both devices across approximately 10 weeks. The focus is on safety (skin injury) assessed by the Draize Scale and efficacy measured by urine capture rate.

How Is the Trial Designed?

Group I: Treatment Sequence 2 Experimental Treatment 2 Interventions

The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System.

Group II: Treatment Sequence 1 Experimental Treatment 2 Interventions

The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch.

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

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/18/NCT05710718/SAP_001.pdf

Statistical Analysis Plan To compare efficacy and safety of PureWick™. System and Hollister®. Female Urinary Pouch. External Collection. Device. Primary. • Efficacy – ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05710718?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Becton,%20Dickinson%20and%20Company%22)&viewType=Table&rank=5

PureWick™ France and U.S. At-Home Pilot Study The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. It is designed ...

3. hollister.com hollister.com/en/products/continence-care-products/urine-collectors/urine-collection-accessories/female-urinary-pouch-external-collection-device

Female Urinary Pouch External Collection Device The female urinary pouch helps manage urine output for non-ambulatory female patients. Features. Cut-to-fit SoftFlex™ skin barrier provides custom fit and ...

4. withpower.com withpower.com/trial/phase-enuresis-2023-78b0f

Urinary Collection Devices for Bedwetting Trial Overview The study compares two devices: PureWick™ System and Hollister® Female Urinary Pouch External Collection Device for managing nighttime urinary ...

5. ctv.veeva.com ctv.veeva.com/study/this-study-will-collect-clinical-and-patient-reported-experience-data-from-participants-requiring-ur

This Study Will Collect Clinical and Patient Reported ... This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting.

6. ritewaymed.com ritewaymed.com/product/hollister-female-urinary-pouch/?srsltid=AfmBOopChH-rmRc_LRYVQcLzGVXyIFB9SpoNXKghBrsdL4hUujlyPkas

Hollister Female Urinary Pouch - Drainage Bags & Trays Hollister Female Urinary Pouch provides an effective way to manage urine output for non-ambulatory patients. It is meant to be connected to a leg bag....

7. medicalmonks.com medicalmonks.com/product/hollister-female-urinary-pouch-external-collection-device/?srsltid=AfmBOorYa5IHpIMFsDp0uRxv8iOwiKQ4Rp0OGi4I91MvDrWGlKCrbt3K

Hollister Female Urinary Pouch External Collection Device The female urinary pouch helps manage urine output for non-ambulatory female patients. Features: • Cut-to-fit SoftFlex skin barrier provides custom fit and ...

8. biorelief.com biorelief.com/product/female-urinary-pouch-2

Female External Catheter Urinary Pouch - BioRelief The Female External Catheter Urinary Pouch is a One-piece disposable system for females to collect and divert urine away from the body.