UK PureWick™ At-Home Pilot Study
ConditionUrinary Incontinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBecton, Dickinson and Company
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov