UK PureWickâ„¢ At-Home Pilot Study (NCT07555548) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
UK PureWickâ„¢ At-Home Pilot Study
United Kingdom95 participantsStarted 2026-04
Plain-language summary
The UK PureWickâ„¢ At-Home Study is being carried out to see how well the PureWickâ„¢ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWickâ„¢ Collection System is different, it's placed outside the body .
In this study, researchers want to find out: how effective the PureWickâ„¢ Collection System is in helping women manage urine collection at home, whether patients prefer using PureWickâ„¢ Collection System over the usual catheter, how it affects their sleep, and overall well-being.The PureWickâ„¢ Collection System is intended for the treatment of patients who leak urine (called urine incontinence). The PureWickâ„¢ Collection System is designed to help manage urine in female patients without needing to insert a urinary catheter into the body.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention versus the clinical impact with the use of the PureWickâ„¢ System requiring intervention, documented during a prospective 4-week study period
Timeframe: From enrollment to the end of treatment at 5 weeks
✕. 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.