PureWick at Home: Female External Urine Collection Pilot

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study combines retrospective and prospective data to evaluate the PureWick Female External Catheter System in home care for women with urinary incontinence who previously relied on indwelling catheters. After a 4-week look-back period documenting problematic catheter events, participants undergo a one-week familiarization phase followed by a four-week prospective period using the PureWick system at home. Outcomes include ease of use, patient satisfaction, sleep quality, and overall well-being, with caregivers involved in training during familiarization. The study aims to determine whether the external system can reduce catheter-related problems and improve home management of urinary collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Winfried Huesmann
• Email: winfried.huesmann@bd.com
• Phone: +4915154403197

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.