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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | PureWick System used first, followed by crossover to UltraFlex |
|
| Treatment Sequence 2 | Experimental | UltraFlex is used first, followed by crossover 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 |
|---|---|---|
| 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. | From enrollment up to 14 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment up to 14 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Device Adherence/Dislodgement | Proportion of device wear nights that each device became dislodged. | From enrollment up to 14 days of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Wagg | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeview Clinical Research, LLC | Guntersville | Alabama | 35976 | United States | ||
| American Institute of Research |
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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. |
|
| 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. | 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. | 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. | Starting at baseline and then after Day 7 and after Day 14 |
| Los Angeles |
| California |
| 90017 |
| United States |
| Finlay Medical Research | Greenacres City | Florida | 33467 | United States |
| Finlay Medical Research | Miami | Florida | 33126 | United States |
| Trialfinity Clinical Research Center | Hamilton | New Jersey | 08619 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Prime Global Research | The Bronx | New York | 10456 | United States |
| Monroe Biomedical Research | North Charleston | South Carolina | 29406 | United States |
| 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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