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A Pilot Study to Evaluate PureWick for Nocturia
N/A
Waitlist Available
Led By Bilal Chughtai, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the PureWick System, a device that helps older adults urinate without getting out of bed. The PureWick System aims to reduce nighttime falls and improve sleep quality for those with frequent nighttime urination.
Eligible Conditions
- Nocturia
- Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in average number of nocturnal voids at baseline and at 3 months
Change of scores on the N-QoL at baseline and at 3-months
The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night
Secondary study objectives
Change in the incidence of pressure ulcers/skin breakdown at baseline and 3 months
Change in the incidence of urinary tract infection (UTI) at baseline and 3 months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: The PureWick Urine Collection SystemExperimental Treatment1 Intervention
The PureWick Urine Collection System is intended for non-invasive urine output management. It pulls urine through tubing that is connected to a collection canister for proper disposal. It is designed to be used by patients, caregivers, or healthcare professionals in both home environments and professional care facilities.
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?
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,094 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,705 Total Patients Enrolled
Becton, Dickinson and CompanyIndustry Sponsor
75 Previous Clinical Trials
90,387 Total Patients Enrolled
Bilal Chughtai, MDPrincipal InvestigatorWeill Medical College of Cornell University
5 Previous Clinical Trials
343 Total Patients Enrolled