UK PureWick™ At-Home Pilot Study

Sponsor
Becton, Dickinson and Company
Study ID
NCT07555548
Status
Recruiting
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Conditions

  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
May 6, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
95 participants (estimated)

Primary Outcome Measure

Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention versus the clinical impact with the use of the PureWick™ System requiring intervention, documented during a prospective 4-week study period [ Time Frame: From enrollment to the end of treatment at 5 weeks ]

Central Contacts

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