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Behavioural Intervention

PureWick System for Urinary Incontinence (PUREST Trial)

N/A
Waitlist Available
Research Sponsored by C. R. Bard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently use diapers or equivalent at night for urine output management
Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent
Must not have
Has moderate to heavy menstruation and cannot use a tampon or menstrual cup
Has urinary tract, vaginal or other chronic infections, active genital herpes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the end of treatment at 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how well the PureWick™ System works and how people feel about using it at home. Researchers will also check if the device is safe and ask participants about how their quality

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, potential issues may include skin irritation or discomfort from using external collection devices like the PureWick System or urinary pouches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use diapers or similar products at night for bladder control.
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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience heavy periods and cannot use tampons or menstrual cups.
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I have ongoing infections, including in the urinary tract or genital herpes.
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I have trouble emptying my bladder completely.
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I have a wound or irritation on my genital area or lower back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of treatment at 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of treatment at 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Performance of the PureWick System in the home setting
Safety of the PureWick System in the home setting
Secondary study objectives
Participant Device Experience - Comfort
Participant Device Experience - Ease of Use
Participant Device Tolerance
Other study objectives
Nocturnal Incontinence related Quality of Life
Participant Sleep Quality

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PureWickExperimental Treatment1 Intervention
Group II: HollisterActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PureWick System
2024
N/A
~50

Find a Location

Who is running the clinical trial?

C. R. BardLead Sponsor
106 Previous Clinical Trials
39,807 Total Patients Enrolled
Becton, Dickinson and CompanyIndustry Sponsor
75 Previous Clinical Trials
90,277 Total Patients Enrolled
~100 spots leftby Jun 2025
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