UK PureWick™ At-Home Pilot Study

NCT07555548 | Not Yet Recruiting FDA Device

• 1 other identifier: UCC-24HC014
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Urinary Incontinence

Keywords

UTI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To compare the possible pain intensity between subjects treated with the PureWick™ System and those with problematic indwelling urinary catheters

  From enrollment to the end of treatment at 5 weeks

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients managed in a home care setting.

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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

NCAS- Northamptonshire Continence Advisory Service

Northampton, NN3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Winfried Huesmann

CONTACT

+4915154403197; winfried.huesmann@bd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

GB (1)