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New external catheter could replace painful internal tubes for women

NCT ID NCT07555548

Symptom relief Sponsor: Becton, Dickinson and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Updated 2 times

Summary

This study tests a new device called the PureWick™ System, a catheter that stays outside the body, for women with urinary incontinence who currently use internal catheters. Researchers want to see if it causes fewer problems like infections or blockages, and if women prefer it. About 95 women in the UK who have had frequent catheter issues will try the device for four weeks at home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PureWick™ Female External Catheter System
What this could lead to
If it works, this could offer women a more comfortable, less infection-prone way to manage urinary incontinence at home without an internal catheter.
What could go wrong
This is a small pilot study with only 95 participants, so results may not apply to everyone. The device may still cause leaks or skin irritation, and it's not a cure for incontinence.

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.

Participants

About 95 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

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.

Who is studied

Female patients managed in a home care setting.

Ages

18 years and older

Sex

Female 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 Female Subjects \>18 years of age at the time of signing the informed consent. 2. Treated with indwelling catheters for at least four weeks 3. Encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation; 4. Willing to comply with all study procedures in this protocol 5. The subject (or subject's power of attorney) must be willing and able to read, understand, sign, and date the informed consent form. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: 1. Has frequent episodes of bowel incontinence without a fecal management system in place; or 2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or 3. Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes; or 4. Is agitated, combative, and/or uncooperative and may remove the external catheter; or 5. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or 6. Has any pre-existing neurological, psychiatric, or other conditions that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or 7. Is known to be pregnant at time of enrollment (for women of childbearing age); or 8. Has a confirmed diagnosis of urinary tract infection at the time of enrollment. 9. Subjects with a urine output of ≥1800 mL over a 12-hour period who, or whose caregivers, are unable to independently empty the collection canister. 10. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

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Conditions

The condition(s) this trial relates to.

Urinary Incontinence

As listed by the trial registrant

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

Urinary incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • East of England Community Health and Care NHS Trust

    RECRUITING

    Norwich, NR2 4BX, United Kingdom

  • NCAS- Northamptonshire Continence Advisory Service

    RECRUITING

    Northampton, NN3 6NP, United Kingdom

  • Rotherham Doncaster and South Humber NHS Foundation Trust

    RECRUITING

    Doncaster, United Kingdom

  • South Leicestershire Medical Group

    RECRUITING

    Leicester, United Kingdom

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