PureWick System 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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

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

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