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
This trial does not accept healthy volunteersQualifiers
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 population
Female patients managed in a home care setting.
Trial design
Design model
Cohort
Time perspective
Other
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
Procedure/SurgeryAfter 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.
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
From enrollment to the end of treatment at 5 weeksSecondary outcomes
1
To compare the possible pain intensity between subjects treated with the PureWick™ System and those with problematic indwelling urinary catheters
• Comparison of the pain intensity measured with the Numeric Pain Rating Scale associated with the PureWick™ System, prospectively documented over a 4-week observation period, versus the retrospectively recorded 4-week associated with indwelling urinary catheters. The Numeric Pain Rating score rates from 0 to 10, whereby 0 represents no pain and 10 worst possible pain.
Time frame
From enrollment to the end of treatment at 5 weeksSponsors and contacts
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Source ClinicalTrials.gov