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

NCT ID: NCT06850259

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-21
• Study Completion Date: 2025-06-15

Brief Summary

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.

Detailed 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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment Sequence 1

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

Group Type: EXPERIMENTAL

PureWick™ System

Intervention Type: DEVICE

The PureWick™ System consists of the PureWick™ Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick™ MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt.

UltraFlex™ Self-Adhering Male External Catheter

Intervention Type: DEVICE

UltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence.

Treatment Sequence 2

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

Group Type: EXPERIMENTAL

PureWick™ System

Intervention Type: DEVICE

The PureWick™ System consists of the PureWick™ Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick™ MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt.

UltraFlex™ Self-Adhering Male External Catheter

Intervention Type: DEVICE

UltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence.

Interventions

PureWick™ System

The PureWick™ System consists of the PureWick™ Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick™ MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt.

Intervention Type: DEVICE

UltraFlex™ Self-Adhering Male External Catheter

UltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: collaborator

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Finlay Medical Research

Greenacres City, Florida, United States

Trialfinity Clinical Research Center

Hamilton, New Jersey, United States

Countries

United States

Other Identifiers

UCC-24HC013

Identifier Type: -

Identifier Source: org_study_id