An observational study in Urinary Incontinence, sponsored by Becton, Dickinson and Company. Recruiting at 4 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Becton, Dickinson and Company · Observational
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 95 is below the median of 120 across 215 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Becton, Dickinson and Company is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female patients managed in a home care setting.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 weeks
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 weeks
Plan to share: Undecided
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