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

NCT06850259 | Completed FDA Device

• 1 other identifier: UCC-24HC013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Incontinence

Keywords

PureWick Urine Collection System; male external catheter; urinary incontinence; urine management; nocturia; nocturnal enuresis

Outcome Measures

Primary Outcomes (2)

• Performance of the PureWick MEC in the Home Setting

  Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) \* 100.

  Daily for 7 days during each treatment phase

• Number of device-related Adverse events requiring medical intervention

  Number of device-related Adverse events requiring medical intervention, such as new prescription medication, surgery or procedure, or therapy ordered by a medical provider to treat or manage the adverse event, in each treatment group.

  Daily for 7 days during each treatment phase

Secondary Outcomes (3)

• Participant Device Preference

  After completion of both 7-day treatment phase or at the time of treatment discontinuation, whichever comes first.

• Participant Device Tolerance

  After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first.

• Device Adherence/Dislodgement

  After completion of each 7-day treatment phase or at the time of treatment discontinuation, whichever comes first.

Other Outcomes (1)

• Participant Sleep Quality

  Starting at baseline and then after completion of each 7 day treatment phase.

Study Arms (2)

Treatment Sequence 1

EXPERIMENTAL

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

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

Treatment Sequence 2

EXPERIMENTAL

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

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

Interventions

PureWick™ System 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.

Treatment Sequence 1; Treatment Sequence 2

UltraFlex™ Self-Adhering Male External Catheter 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 1; Treatment Sequence 2

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Adult male participants ≥ 65 years of age at the time of signing the informed consent
• Male anatomy at the time of enrollment
• Currently use diapers, pads, or equivalent at night for urine output management
• Willing to comply with all study procedures in this protocol
• Provision of signed and dated informed consent form

You may not qualify if:

• Has frequent episodes of bowel incontinence; or
• Has chronic urinogenital infections, active genital herpes; or
• Has Urinary retention; or
• Has experience using study devices in the home setting within the last year; or
• Is agitated, combative, and/or uncooperative and may remove the external catheter; or
• Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
• Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
• Is considered a vulnerable population.

Sponsors & Collaborators

• C. R. Bard: lead
• Becton, Dickinson and Company: collaborator

Study Sites (2)

Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

Trialfinity Clinical Research Center

Hamilton, New Jersey, 08619, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Nocturia; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 27, 2025
• Study Start: March 21, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)