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A Pilot Study to Evaluate PureWick for Nocturia

NCT05090722 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Nocturia

Interventions

DEVICE

PureWick System

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.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    collaborator INDUSTRY

  • Northwell Health

    lead OTHER

Principal Investigators

  • Bilal Chughtai, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2026-10-31
Completion
2027-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090722 on ClinicalTrials.gov