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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | PureWick™ System is used first, followed by cross-over to UltraFlex™ |
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| Treatment Sequence 2 | Experimental | UltraFlex™ is used first, followed by cross-over to PureWick™ System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PureWick™ System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the PureWick MEC 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. | Daily for 7 days during each treatment phase |
| 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. | Daily for 7 days during each treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After completion of both 7-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Starting at baseline and then after completion of each 7 day treatment phase. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Finlay Medical Research | Greenacres City | Florida | 33467 | United States | ||
| Trialfinity Clinical Research Center |
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| UltraFlex™ Self-Adhering Male External Catheter | Device | 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. |
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| Participant Device Tolerance | Participant's tolerability is determined by the number of days of actual device use | After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
| Device Adherence/Dislodgement | Proportion of device wear nights that each device became dislodged. | After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
| Hamilton |
| New Jersey |
| 08619 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053158 | Nocturia |
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004775 | Enuresis |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
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