An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males (PUREST-M)

C. R. Bard

Status: Invitation-only

Conditions: Urinary Incontinence

Treatments: Device: UltraFlex Self-Adhering Male External Catheter; Device: PureWick System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07282860

UCC-25HC015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male participants ≥ 18 years of age at the time of signing the informed consent
2. Male anatomy at the time of enrollment
3. Currently use diapers, pads, or equivalent at night for urine output management
4. Willing to comply with all study procedures in this protocol
5. Provision of signed and dated informed consent form

Exclusion criteria

1. Has frequent episodes of bowel incontinence; or
2. Has chronic urinogenital infections, active genital herpes; or
3. Has Urinary retention; or
4. Is expected to have an overnight urine output exceeding 1500 mL. This may include, but is not limited to, individuals with polyuria or those receiving diuretic therapy; or
5. Has experience using study devices in the home setting within the last year; or
6. Is agitated, combative, and/or uncooperative and may remove the external catheter; or
7. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
8. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
9. Is considered a vulnerable population.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment Sequence 1

Experimental group

Description:

PureWick System used first, followed by crossover to UltraFlex

Treatment:

Device: UltraFlex Self-Adhering Male External Catheter

Device: PureWick System

Treatment Sequence 2

Experimental group

Description:

UltraFlex is used first, followed by crossover to PureWick System

Treatment:

Device: UltraFlex Self-Adhering Male External Catheter

Device: PureWick System