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UK PureWick™ At-Home Pilot Study

NCT07555548 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2026-07-13

No results posted yet for this study

Summary

The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWick™ Collection System is different, it's placed outside the body .

In this study, researchers want to find out: how effective the PureWick™ Collection System is in helping women manage urine collection at home, whether patients prefer using PureWick™ Collection System over the usual catheter, how it affects their sleep, and overall well-being.The PureWick™ Collection System is intended for the treatment of patients who leak urine (called urine incontinence). The PureWick™ Collection System is designed to help manage urine in female patients without needing to insert a urinary catheter into the body.

Conditions

Interventions

PROCEDURE

Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence

After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWick™ Female External Catheter System.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2026-11-30
Completion
2027-01-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT07555548 on ClinicalTrials.gov