An interventional study of PureWick® Urine Collection System and UltraFlex™ Self-Adhering Male External Catheter in Urinary Incontinence, sponsored by C. R. Bard. Completed at 2 sites in United States. Open to male participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
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 15 men requiring the use of diapers or pads 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 efficacy endpoint is the mean capture rate. The primary safety endpoint is the number of device-related AEs requiring medical intervention. Capture rates and Adverse Events are assessed daily throughout each 7-day treatment phase. Sleep disturbance is assessed at baseline and every 7 days during treatment. End of study preference questionnaire is completed at the end of treatment. Device adherence is assessed by the proportion of device wear nights that the study device became dislodged. Tolerability is assessed by number of nights of actual device use.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's enrollment of 15 is below 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.
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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® Urine Collection System is used first, followed by cross-over to UltraFlex™ Self-Adhering Male External Catheter
Device: PureWick® Urine Collection System · Device: UltraFlex™ Self-Adhering Male External Catheter
UltraFlex™ Self-Adhering Male External Catheter is used first, followed by cross-over to PureWick® Urine Collection System
Device: PureWick® Urine Collection 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.
Average Daily Urine Capture Rate (Percentage) in the Home Setting
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: Daily for 7 days during each treatment phase, up to 14 days post-baseline
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: Daily for 7 days during each treatment phase, up to 14 days post-baseline
Participant Device Preference
Preference questionnaire administered after completion of both treatments to assess participant device satisfaction and preference for the PureWick MEC or UltraFlex sheath-style male external catheter. Participants will select which of the two devices they preferred and provide feedback on why the preferred device was selected.
Time frame: After completion of both 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Participant Device Tolerance
Participant's tolerability is determined by the number of days of actual device use
Time frame: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
Device Adherence/Dislodgement
Proportion of device wear nights that each device became dislodged.
Time frame: After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first, assessed up to 2 weeks
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 ranging from 32.0 to 73.3, where higher scores indicate a worse outcome.
Time frame: Starting at baseline and then after completion of each 7 day treatment phase, assessed up to 2 weeks
Male subjects were identified and enrolled by two participating clinical research sites between March and June 2025.
| Milestone | Treatment Sequence 1 | Treatment Sequence 2 |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
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.
| Percentage of urine captured/day | PureWick® Urine Collection System | UltraFlex™ Self-Adhering Male External Catheter |
|---|---|---|
| Overall | 98.476 ± 1.68 | 98.063 ± 2.55 |
| Treatment Phase 1 | 97.975 ± 1.61 | 97.81 ± 3.42 |
| Treatment Phase 2 | 99.049 ± 1.68 | 98.287 ± 1.70 |
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.
| Number of device-related adverse events | PureWick® Urine Collection System | UltraFlex™ Self-Adhering Male External Catheter |
|---|---|---|
| Number of Device-related Adverse Events Requiring Medical Intervention | 0 | 0 |
Preference questionnaire administered after completion of both treatments to assess participant device satisfaction and preference for the PureWick MEC or UltraFlex sheath-style male external catheter. Participants will select which of the two devices they preferred and provide feedback on why the preferred device was selected.
| Participants | PureWick® Urine Collection System | UltraFlex™ Self-Adhering Male External Catheter |
|---|---|---|
| Participant Device Preference | 13 | 2 |
Participant's tolerability is determined by the number of days of actual device use
| Number of Nights of Actual Device Use | PureWick® Urine Collection System | UltraFlex™ Self-Adhering Male External Catheter |
|---|---|---|
| Participant Device Tolerance | 7 ± 0 | 7 ± 0 |
Proportion of device wear nights that each device became dislodged.
| Percentage of dislodgement nights | PureWick® Urine Collection System | UltraFlex™ Self-Adhering Male External Catheter |
|---|---|---|
| Overall | 5.714 ± 13.0 | 1.905 ± 5.03 |
| Treatment Phase 1 | 10.714 ± 16.64 | 2.041 ± 5.40 |
| Treatment Phase 2 | 0 ± 0 | 1.786 ± 5.05 |
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 ranging from 32.0 to 73.3, where higher scores indicate a worse outcome.
| score on a scale | PureWick® Urine Collection System | UltraFlex™ Self-Adhering Male External Catheter |
|---|---|---|
| Baseline | 53.22 ± 6.17 | 53.22 ± 6.17 |
| Day 7 | 44.61 ± 6.54 | 46.89 ± 4.60 |
| Day 7 Change from baseline | -8.61 ± 9.27 | -6.33 ± 7.56 |
Collected over 7 days during each treatment phase, an average of two weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PureWick® Urine Collection System | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| UltraFlex™ Self-Adhering Male External Catheter | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(Years) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Mean | 73.5 ± 6.0 | 76.6 ± 3.9 | 74.9 ± 5.2 |
| Sex: Female, Male(Participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 8 | 7 | 15 |
| Race (NIH/OMB)(Participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 7 | 14 |
| Not Hispanic or Latino | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Primary Diagnosis(Participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Urinary Incontinence | 4 | 1 | 5 |
| Nocturia | 1 | 4 | 5 |
| Reduced Mobility | 2 | 2 | 4 |
| Other | 1 | 0 | 1 |
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