PureWick™ France and U.S. At-Home Pilot Study

Study Overview
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Brief Summary
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In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.

Detailed Description
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In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. Approximately 30 female participants from 2 sites will be enrolled into the study. Those meeting eligibility criteria will be treated according to the treatment sequence assigned during randomization. Participants will view the standardized training video for the applicable product at the beginning of each treatment phase and have access to the Information for Use document (IFU) to review during each treatment phase. The total expected duration of subject participation is approximately 10 weeks. Participants will use the device assigned in treatment phase 1 overnight while sleeping for 4 weeks (28 days) before transitioning to the second assigned device in treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 weeks) between treatment phases and a re-screening of eligibility criteria before the second phase. In both treatment phases, participants will independently place and remove the FEC (female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is completed on the first day of the treatment phase. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate. Health Care Providers (HCPs) will visit participants' homes daily to perform a skin assessment and collect urine measurements during the treatment phases. Participants will be withdrawn from the treatment phase if grade 4 is achieved in any category on the Draize skin irritation scale. The secondary objectives are to assess quality of life, tolerability, comfort and ease of use. Quality of life and comfort and ease of use will be measured using self-reported changes in quality of life via the validated Nocturia Quality of Life (N-Qol) tool and subjective evaluation of the therapy via participant survey, respectively. Tolerability will be measured by number of days of actual use of both devices, and discontinuation rate attributed to the device's discomfort or inconvenience.

Official Title
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A Comparative Crossover Study on the Safety, Efficacy, and Patient Quality of Life Comparing PureWick™ System With an Established Comparator in the Home Setting for Incontinence Overnight

Conditions
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Nocturnal Enuresis

Intervention / Treatment
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* Device: PureWick™ System
* Device: Hollister® Female Urinary Pouch External Collection Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Female Participants >18 years of age at the time of signing the informed consent. Currently use diapers or equivalent at night for urine capture (Change complet(French term)) Willing to comply with all study procedures in this protocol Provision of signed and dated informed consent form Exclusion Criteria: Has frequent episodes of bowel incontinence without a fecal management system in place; or Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or Has Urinary tract, vaginal or other chronic infections, active genital herpes; or Has Urinary retention; or Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or Is known to be pregnant at time of enrollment (for women of childbearing age); or Any other condition that, in the opinion of the investigator, would preclude them from participating in the study. Is under supervision of a legally authorized representative.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 1:1 Crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PureWick™ System<br>The PureWick™ System includes the PureWick™ Female External Catheter and the PureWick™ Urine Collection System. The PureWick™ Female External Catheter (PureWick™ FEC) is marketed in both the United States and Europe. In the U.S. PureWick™ FEC is a Class I, 510(k) exempt device. In Europe, the PureWick™ FEC is a Class I, Conformitè Europëenne (CE) marked, non-sterile device. | Device: PureWick™ System<br>* The PureWick™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC will be connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body.<br>|
| Active Comparator: Hollister® Female Urinary Pouch External Collection Device<br>The urinary collection pouch with a skin barrier is suitable for non-ambulatory females with urinary incontinence. | Device: Hollister® Female Urinary Pouch External Collection Device<br>* It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily urine capture rate (percentage) | Urine weight captured in the device divided by the sum of urine weight captured in the device plus the leaked urine weight | Daily for 29 days during each treatment phase | 
| Daily skin irritation score using the Draize Scale | Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding. | Daily for 29 days during each treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturia Quality of Life (N-QOL) score | N-QOL is a standardized tool used to explore 13 items that might be affected by nocturia (e.g., concentration, productiveness, and low energy | Starting at baseline and then every 2 weeks during each treatment phase | 
| Participant's tolerability of device/treatment | Participant's tolerability will be determined by the number of days of actual use of both devices and the discontinuation rate attributed to the device's inconvenience to the participants. | Daily for 29 days during each treatment phase or until end of device use for each treatment phase | 
| Participant's comfort level associated with device/treatment | Overall comfort will determine by having the participants complete a survey with scores on a 5-point Likert scale collected at the end of each treatment phase | Daily use of for 29 days during each treatment phase and one survey collected at the end of each treatment phase | 
| Participant's opinion of ease of device/treament | Overall ease of use will determine by having the participants complete a survey with scores on a 5-point Likert scale collected at the end of each treatment phase. | Daily use of for 29 days during each treatment phase and one survey collected at the end of each treatment phase |