Urinary Collection Devices for Bedwetting

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

17 Participants Needed

Trial Summary

What is the purpose of this trial?

In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.

Eligibility Criteria

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

Provision of signed and dated informed consent form

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

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

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

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

Treatment Details

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.

Participant Groups

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