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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment Sequence 1

PureWick System used first, followed by crossover 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 crossover 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

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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

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No