UK PureWick™ At-Home Pilot Study

NCT07555548 · tracked via the Priya Life Science UK tracker

Sponsor

Becton, Dickinson and Company

Phase

Observational

Started

2026-05-06

Last updated

2026-07-13

Condition(s) studied

Urinary Incontinence

Investigational drug(s) / intervention(s)

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

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.

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adult Female Subjects \>18 years of age at the time of signing the informed consent. 2. Treated with indwelling catheters for at least four weeks 3. Encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation; 4. Willing to comply with all study procedures in this protocol 5. The subject (or subject's power of attorney) must be willing and able to read, understand, sign, and date the informed consent form. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: 1. Has frequent episodes of bowel incontinence without a fecal management system in place; or 2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or 3. Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes; or 4. Is agitated, combative, and/or uncooperative and may remove the external catheter; or 5. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or 6. 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 7. Is known to be pregnant at time of enrollment (for women of childbearing age); or 8. Has a confirmed diagnosis of urinary tract infection at the time of enrollment. 9. 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. 10. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Primary outcome measure(s)

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 — From enrollment to the end of treatment at 5 weeks
Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention by the treating HCP, based on medical records from the 4-week period preceding subject enrollment versus the clinical impact with the use of the PureWick™ System requiring intervention by the treating HCP during the prospective 4-week study period. * Clinical impact for indwelling urinary catheters is defined as frequency and type of catheter-related problems such as infections, blockages, dislodgements, leakages, expulsion and bypassing, requiring intervention * Clinical impact with the use of the PureWick™ System is defined as frequency and types of PureWick™ System-related problems such as infections, leakages, dislodgements, and replacements, requiring intervention. * Subject-reported impact on daily activities measured by procedure and device related Adverse Events * Health Care interventions required due to catheter-related issues incl. nursing time versus

Trial sites (4)

Facility	City	Region	Status
Rotherham Doncaster and South Humber NHS Foundation Trust	Doncaster	United Kingdom	Recruiting
South Leicestershire Medical Group	Leicester	United Kingdom	Recruiting
NCAS- Northamptonshire Continence Advisory Service	Northampton	United Kingdom	Recruiting
East of England Community Health and Care NHS Trust	Norwich	United Kingdom	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07555548 on ClinicalTrials.gov ↗ ← All trials in the UK