40 Participants NeededMy employer runs this trial

PureWick for Nocturia

ML
RB
SS
BC
JP
Overseen ByJennifer Polo, CCRC
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the PureWick System, a device designed to manage nocturia, the need to urinate multiple times during the night. The researchers aim to determine if this system can reduce nighttime falls that occur when getting up to use the bathroom. Women aged 50 and older who wake up to urinate at least twice each night may be suitable candidates for this trial. Researchers will monitor participants for three months to gather information on the device’s impact on sleep and any side effects.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance nighttime safety and sleep quality.

What prior data suggests that the PureWick System is safe for managing nocturia?

Research has shown that the PureWick System is generally safe for managing urinary incontinence. Studies have found that it keeps users dry most of the time, with 88% of participants experiencing positive results. Notably, about 52% of users reported no skin problems. However, due to limited information on long-term safety, regular check-ups remain important. The device is non-invasive, meaning it doesn't involve surgery or entering the body, which typically makes it safer than invasive options. Always follow the manufacturer's instructions, such as unplugging it when cleaning, to prevent any issues.12345

Why are researchers excited about this trial?

Researchers are excited about the PureWick System for managing nocturia because it offers a non-invasive way to handle urine output. Unlike traditional methods like catheters, which can be uncomfortable and increase infection risk, PureWick uses a suction-based mechanism that eliminates the need for insertion into the body. This system can be used conveniently at home or in care facilities by patients, caregivers, and healthcare professionals, making it a versatile and user-friendly option.

What evidence suggests that the PureWick System is effective for managing nocturia and reducing nighttime falls?

Research has shown that the PureWick System, used by participants in this trial, effectively manages urinary incontinence, aids bladder control, and keeps users dry overnight. Studies have found that it captures urine efficiently, with success rates of about 90% or more. As a non-invasive device, it operates externally and is designed to prevent skin problems by keeping moisture away. A randomized trial found it to be a safe and easy-to-use option for managing nighttime urine at home. Many users prefer it over traditional methods like pads, citing its convenience and effectiveness.25678

Who Is on the Research Team?

BC

Bilal Chughtai, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for women aged 50 or older who get up to urinate at least twice each night. Participants must be able to use the PureWick system and complete study questionnaires. Those with open wounds in the genital area, certain neurological or psychiatric issues, or who can't operate the device are not eligible.

Inclusion Criteria

Experiences 2 or more voids per night as assessed on a 3-day bladder diary.
Women aged 50 years or older.
Women aged 50 years or older
See 1 more

Exclusion Criteria

Unable to operate the PureWick system
Unable to complete required questionnaires and diaries
Investigator deems subject as unsuitable for enrollment.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the PureWick Urine Collection System for nocturia management

3 months
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • PureWick System

Trial Overview

The study is testing the PureWick System, a device designed to help manage nighttime urination (nocturia) and possibly reduce falls when getting up at night. The effects will be monitored over three months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: The PureWick Urine Collection SystemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

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

Safety, Efficacy, and Patient-Reported Outcomes of the ... - PMC

Average urine capture rates were similar between PureWick and Hollister (mean: 90.9% vs. 87.9%; median: 95.4% vs. 97.3%), and mean Draize Scale ...

AN OBSERVATIONAL STUDY OF THE PUREWICK™ ...

The overall opinion of PureWick was positive compared with pads, with 64% of care/nursing home users choosing to continue using PureWick beyond ...

Outpatient PureWick™ female external catheter system ...

The PureWick™ female external catheter provides a non-invasive method to manage female urinary incontinence, measure urinary output, and reduce skin ...

NCT06850259 | This Study Will Collect Clinical and Patient ...

This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.

Results of a Randomized Trial.

Conclusions: PureWick offers a safe, effective, and patient-friendly option for independently managing nocturnal UI in the home setting.

The BD PureWick™ System - Official Site

At home, the PureWick™ Urine Collection System can provide a better option for managing nighttime urinary incontinence. It helps reduce trips to the bathroom, ...

PureWick® Urine Collection System

Safety and Warnings: Always unplug PureWick® Urine Collection System before cleaning or when not in use. DO NOT IMMERSE THE PUREWICK® URINE COLLECTION SYSTEM ...

Decision Summary

The long term safety and benefit of Purewick® is unknown and there is no published safety data available on the use of the Purewick®.