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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 experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.
Approximately 150 women with nighttime urinary incontinence will take part in this prospective, open-label, randomized trial. Participants will use one of two different study devices during the study to manage urine output at night: PureWick™ System or the Hollister® Female Urinary Pouch External Collection Device. Participant device assignment will be random. Participants will use the assigned urine management device overnight while sleeping and will be followed for approximately 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hollister | Active Comparator |
| |
| PureWick | Experimental |
|
| 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 Flex Female External Catheter, which are intended for non-invasive urine output management. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the PureWick System in the home setting | Daily capture rate (captured as % of urine captured by device and collected in canister, measured by weight) | From enrollment to the end of treatment at 4 weeks |
| Safety of the PureWick System in the home setting | Daily skin irritation score using the 5-point Draize dermal irritation scoring system ranging from 0 to 4 with higher scores indicating greater irritation. | From enrollment to the end of treatment at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Device Tolerance | Number of days of actual device use over the expected treatment duration. | From enrollment to the end of treatment at 4 weeks |
| Participant Device Experience - Comfort |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Incontinence related Quality of Life | Nocturia Quality of Life (N-QOL) score collected at baseline and every 2 weeks during treatment with higher scores indicating better QoL. The NQoL contains 12 scored items each scored from 0 to 4. All item scores are computed into a total score ranging from 0-100 where 0 is the worst QoL and 100 is the best QoL. | From enrollment to the end of treatment at 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | United States | ||
| New Horizons Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41464602 | Derived | Medina JC, Fakih M, Khalsa S, Redmond D, Kennelly MJ. Safety, Efficacy, and Patient-Reported Outcomes of the PureWick System Versus Comparator for Nocturnal Urinary Incontinence in the Home Setting: Results of a Randomized Trial. J Clin Med. 2025 Dec 9;14(24):8699. doi: 10.3390/jcm14248699. |
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| Hollister Female Urinary Pouch External Collection Device | Device | The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. |
|
Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome.
| From enrollment to the end of treatment at 4 weeks |
| Participant Device Experience - Ease of Use | Overall ease of use on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome. | From enrollment to the end of treatment at 4 weeks |
| Participant Sleep Quality | PROMIS Sleep Disturbance Short Form 4a score collected at baseline and every 7 days during treatment with higher scores indicating greater sleep disturbance. 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. | From enrollment to the end of treatment at 4 weeks |
| Chandler |
| Arizona |
| 85224 |
| United States |
| The Practice of Medicine INC. | Eagle Rock | California | 90041 | United States |
| Finlay Medical Research | Greenacres City | Florida | 33467 | United States |
| Finlay Medical Research | Miami | Florida | 33126 | United States |
| Smith Medical Center | Dunwoody | Georgia | 30338 | United States |
| Sonar Clinical Research | Riverdale | Georgia | 30274 | United States |
| Leavitt Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Research Integrity | Owensboro | Kentucky | 42303 | United States |
| Revive Research Institute | Dearborn Heights | Michigan | 48127 | 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 |
| MultiSpecialty Clinical Research | Johnson City | Tennessee | 37604 | United States |
| Trio Clinical Trials | Houston | Texas | 77008 | United States |
| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| D014549 | Urinary Incontinence |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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