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The UK PureWickâ„¢ At-Home Study is being carried out to see how well the PureWickâ„¢ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWickâ„¢ Collection System is different, it's placed outside the body .
In this study, researchers want to find out: how effective the PureWickâ„¢ Collection System is in helping women manage urine collection at home, whether patients prefer using PureWickâ„¢ Collection System over the usual catheter, how it affects their sleep, and overall well-being.The PureWickâ„¢ Collection System is intended for the treatment of patients who leak urine (called urine incontinence). The PureWickâ„¢ Collection System is designed to help manage urine in female patients without needing to insert a urinary catheter into the body.
This is a combination of a retrospective / prospective, open-label, pilot study which aims to assess the clinical benefits of the PureWickâ„¢ Female External Catheter System compared to indwelling urinary catheters in female patients managed in a home care setting.
After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWickâ„¢ Female External Catheter System.
The familiarization period will serve as a training phase, allowing both subjects and caregivers to receive instruction and adapt to the use of the study device.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with the PureWickâ„¢ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence | Procedure | After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWickâ„¢ Female External Catheter System. |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention versus the clinical impact with the use of the PureWickâ„¢ System requiring intervention, documented during a prospective 4-week study period | Retrospective assessment of the clinical impact of problematic indwelling urinary catheters requiring intervention by the treating HCP, based on medical records from the 4-week period preceding subject enrollment versus the clinical impact with the use of the PureWickâ„¢ System requiring intervention by the treating HCP during the prospective 4-week study period.
| From enrollment to the end of treatment at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the possible pain intensity between subjects treated with the PureWick™ System and those with problematic indwelling urinary catheters | • Comparison of the pain intensity measured with the Numeric Pain Rating Scale associated with the PureWick™ System, prospectively documented over a 4-week observation period, versus the retrospectively recorded 4-week associated with indwelling urinary catheters. The Numeric Pain Rating score rates from 0 to 10, whereby 0 represents no pain and 10 worst possible pain. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria apply:
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Female patients managed in a home care setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Winfried Huesmann | Contact | +4915154403197 | winfried.huesmann@bd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCAS- Northamptonshire Continence Advisory Service | Northampton | NN3 6NP | United Kingdom |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| From enrollment to the end of treatment at 5 weeks |
| 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 |