UK PureWick™ At-Home Pilot Study

An Open-label Pilot Study Conducted in the UK to Evaluate the Clinical Benefits of the PureWick™ Female External Catheter System Compared to Indwelling Urinary Catheters in Female Patients Receiving Home-based Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Procedure: Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence

Detailed Description

This is a combination of a retrospective / prospective, open-label, pilot study which aims to assess the clinical benefits of the PureWick™ Female External Catheter System compared to indwelling urinary catheters in female patients managed in a home care setting.

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.

The familiarization period will serve as a training phase, allowing both subjects and caregivers to receive instruction and adapt to the use of the study device.

• Study Type: Observational
• Enrollment (Estimated): 95

Contacts and Locations

• Study Contact: Name: Winfried Huesmann; Phone Number: +4915154403197; Email: winfried.huesmann@bd.com

Study Locations

• United Kingdom
  • Northampton, United Kingdom, NN3 6NP
    • NCAS- Northamptonshire Continence Advisory Service
    • Contact: Rebecca Willis; Phone Number: +447874882910; Email: Rebecca.Willis@nhft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female patients managed in a home care setting.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From enrollment to the end of treatment at 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the possible pain intensity between subjects treated with the PureWick™ System and those with problematic indwelling urinary catheters	• Comparison of the pain intensity measured with the Numeric Pain Rating Scale associated with the PureWick™ System, prospectively documented over a 4-week observation period, versus the retrospectively recorded 4-week associated with indwelling urinary catheters. The Numeric Pain Rating score rates from 0 to 10, whereby 0 represents no pain and 10 worst possible pain.	From enrollment to the end of treatment at 5 weeks

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: UTI
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Therapeutics
• Other Study ID Numbers: UCC-24HC014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes