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.

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.

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.