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

C. R. Bard

Status: Invitation-only

Conditions: Nocturnal Enuresis

Treatments: Device: PureWick™ System; Device: Hollister® Female Urinary Pouch External Collection Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05710718

UCC-8007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult Female Participants >18 years of age at the time of signing the informed consent.
2. Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))
3. Willing to comply with all study procedures in this protocol
4. Provision of signed and dated informed consent form

Exclusion criteria

1. Has frequent episodes of bowel incontinence without a fecal management system in place; or
2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
3. Has Urinary tract, vaginal or other chronic infections, active genital herpes; or
4. Has Urinary retention; or
5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
7. 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
8. Is known to be pregnant at time of enrollment (for women of childbearing age); or
9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
10. Is under supervision of a legally authorized representative.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

PureWick™ System

Experimental group

Description:

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.

Treatment:

Device: PureWick™ System

Hollister® Female Urinary Pouch External Collection Device

Active Comparator group

Description:

The urinary collection pouch with a skin barrier is suitable for non-ambulatory females with urinary incontinence.

Treatment:

Device: Hollister® Female Urinary Pouch External Collection Device