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New catheter aims to keep men dry at night

NCT ID NCT07282860

Symptom relief Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study compares a new external catheter (PureWick) to a standard one for men who leak urine at night. About 100 adult men who currently use diapers or pads will test each device at home overnight. The goal is to see which device captures more urine, causes fewer skin problems, and is more comfortable to use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Nov 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Nocturia nocturnal enuresis Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary incontinence

Contacts and locations

Locations

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102, United States

  • American Institute of Research

    Los Angeles, California, 90017, United States

  • Eagle Clinical Research

    Chicago, Illinois, 60621, United States

  • Finlay Medical Research

    Greenacres City, Florida, 33467, United States

  • Finlay Medical Research

    Miami, Florida, 33126, United States

  • Inno MDR Clinical

    Hamilton, New Jersey, 08690, United States

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama, 35976, United States

  • Monroe Biomedical Research

    North Charleston, South Carolina, 29406, United States

  • Novak Clinical Research

    Tucson, Arizona, 85741, United States

  • Prime Global Research

    The Bronx, New York, 10456, United States

  • R&H Clinical Research

    Katy, Texas, 77494, United States

  • Sonar Clinical Research

    Atlanta, Georgia, 30315, United States

  • Trialfinity Clinical Research Center

    Hamilton, New Jersey, 08619, United States

  • Trio Clinical Trials

    Houston, Texas, 77008, United States

  • Vida Clinical Studies

    Dearborn Heights, Michigan, 48127, United States

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