A Pilot Study to Evaluate PureWick for Nocturia

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT05090722
Status
Recruiting
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Conditions

  • Nocturia

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PureWick System — DEVICE
    The PureWick system consists of the external catheter, collection tubing, and collection canister with lid. It operates via a power cord that is plugged into the device outlet and the A/C power outlet.

Study Details

This is a single-center prospective pilot study of PureWick used as a management for nocturia and reduction of nighttime falls associated with going to the bathroom. Subjects are followed up to 3 months after the intervention. As a pilot study, it is expected that a 3-month follow-up will adequately capture urinary and sleep outcomes data and any adverse events related or unrelated to the study device.

Key Dates

Start date
Dec 16, 2021
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: The PureWick Urine Collection System
    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.

Primary Outcome Measure

The proportion of patients at 3 months who have a demonstrated 50% or greater reduction in the number of nocturia episodes/night [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065-
Multi-Specialty NHPP SyossetSyossetNew York11791
Bilal Chughtai, MD
[email protected]
516-628-5910
Jennifer Polo, CCRC
[email protected]

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NYMulti-Specialty NHPP Syosset· Syosset, NY

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