An interventional study of PureWick System and UltraFlex Self-Adhering Male External Catheter in Urinary Incontinence, sponsored by C. R. Bard. Completed at 15 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Supportive care
This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.
Approximately 100 adult men requiring the use of diapers, pads or equivalent at night for urine management will take part in this prospective, open-label, crossover trial. Participants will be 1:1 randomized to a treatment sequence using two devices: the PureWick™ System (PureWick™ Male External Catheter \& PureWick™ Urine Collection System) and the UltraFlex™ Self-Adhering Male External Catheter. Participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. Total duration of participation is approximately 16 days. The primary endpoint is the mean urine capture rate. The secondary endpoints include the number of device-related AEs requiring medical intervention (safety), device satisfaction and preference questionnaires, and sleep disturbance (quality of life). Capture rates and adverse events are assessed daily throughout each 7-day treatment phase. Patient satisfaction is assessed at the end of each treatment phase. Patient preference is evaluated at study completion. Sleep disturbance is assessed at baseline and every 7 days during treatment.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's enrollment of 120 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.
First submitted after C. R. Bard became part of Becton, Dickinson and Company.
Counted across the registry records on this site, refreshed daily.
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:
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.
PureWick System used first, followed by crossover to UltraFlex
Device: PureWick System · Device: UltraFlex Self-Adhering Male External Catheter
UltraFlex is used first, followed by crossover to PureWick System
Device: PureWick System · Device: UltraFlex Self-Adhering Male External Catheter
The PureWick™ System consists of the PureWick™ Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick™ MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt.
UltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence.
Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100.
Time frame: From enrollment up to 14 days of treatment
Number of device-related adverse events requiring medical intervention
Number of device-related Adverse events requiring medical intervention, such as new prescription medication, surgery or procedure, or therapy ordered by a medical provider to treat or manage the adverse event, in each treatment group.
Time frame: From enrollment up to 14 days of treatment
Participant Device Satisfaction
Participant experience questionnaire administered after completion of each treatment phase to assess participant device satisfaction. Questions will be scored on a 3-point or 5-point Likert scale with higher scores indicating a better outcome.
Time frame: Day 7 and Day 14, or at the time of treatment discontinuation, whichever comes first.
Participant Device Preference
Participant preference questionnaire administered after completion of both treatment phases to assess preference for the PureWick MEC or UltraFlex sheath-style male external catheter.
Time frame: Day 15, or at the time of study discontinuation, whichever comes first.
Participant Sleep Quality
The PROMIS Sleep Disturbance Short Form 4a score collected at baseline and after each 7-day treatment phase. The PROMIS Sleep Disturbance 4a contains 4 scored items each scored from 1 to 5. All item raw scores are computed into a total score where higher scores indicate a worse outcome.
Time frame: Starting at baseline and then after Day 7 and after Day 14
Device Adherence/Dislodgement
Proportion of device wear nights that each device became dislodged.
Time frame: From enrollment up to 14 days of treatment
Plan to share: No
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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