UK PureWick™ At-Home Pilot Study

Recruiting now

Conditions studied: Urinary Incontinence

In brief

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 facts

Study ID

NCT07555548

Run by

Becton, Dickinson and Company

People needed

95

Starts

2026-05-06

Expected to finish

2027-01-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult Female Subjects >18 years of age at the time of signing the informed consent.
• Treated with indwelling catheters for at least four weeks
• Encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation;
• Willing to comply with all study procedures in this protocol
• The subject (or subject's power of attorney) must be willing and able to read, understand, sign, and date the informed consent form.

You may not qualify if…

• Subjects are excluded from the study if any of the following criteria apply:
• Has frequent episodes of bowel incontinence without a fecal management system in place; or
• Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
• Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes; or
• Is agitated, combative, and/or uncooperative and may remove the external catheter; or
• Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
• Has any pre-existing neurological, psychiatric, or other conditions that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
• Is known to be pregnant at time of enrollment (for women of childbearing age); or
• Has a confirmed diagnosis of urinary tract infection at the time of enrollment.
• Subjects with a urine output of ≥1800 mL over a 12-hour period who, or whose caregivers, are unable to independently empty the collection canister.
• Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Where it is running

• Rotherham Doncaster and South Humber NHS Foundation Trust — Doncaster, United Kingdom (enrolling)
• South Leicestershire Medical Group — Leicester, United Kingdom (enrolling)
• NCAS- Northamptonshire Continence Advisory Service — Northampton, United Kingdom (enrolling)
• East of England Community Health and Care NHS Trust — Norwich, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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