This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting. (PUREST-M)

C. R. Bard

Status: Completed

Conditions: Urinary Incontinence

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06850259

UCC-24HC013

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 15 men requiring the use of diapers or pads 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 efficacy endpoint is the mean capture rate. The primary safety endpoint is the number of device-related AEs requiring medical intervention. Capture rates and Adverse Events are assessed daily throughout each 7-day treatment phase. Sleep disturbance is assessed at baseline and every 7 days during treatment. End of study preference questionnaire is completed at the end of treatment. Device adherence is assessed by the proportion of device wear nights that the study device became dislodged. Tolerability is assessed by number of nights of actual device use.

Enrollment: 15 patients

Sex: Male

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male participants ≥ 65 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. Has experience using study devices in the home setting within the last year; or
5. Is agitated, combative, and/or uncooperative and may remove the external catheter; or
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
7. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
8. 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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15 participants in 2 patient groups

Treatment Sequence 1

Experimental group

Description:

PureWick™ System is used first, followed by cross-over 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 cross-over to PureWick™ System

Treatment:

Device: UltraFlex™ Self-Adhering Male External Catheter

Device: PureWick™ System