A gentler catheter may cut infection risk for women in hospitals

NCT ID NCT07798128

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By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study looks at whether a non-invasive external catheter, called PureWick Flex, can reduce the use of indwelling urinary catheters in hospitalized women with limited mobility and incontinence. Indwelling catheters can cause infections and other complications, so researchers want to see if switching to an external device helps. About 240 women across Europe and the Middle East will be observed, first with standard care using indwelling catheters, then after the external catheter is introduced. The goal is to compare how often indwelling catheters are used and to track infections, comfort, and length of hospital stay.

What this could mean

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

Active substance
PureWick™ Flex Female External Catheter, a non-invasive external urine collection device
What this could lead to
If it works, hospitals could adopt this external catheter to reduce reliance on indwelling catheters, potentially lowering infection rates and improving comfort for women with limited mobility.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by other factors. The device may not significantly change catheter use, and any benefits could vary across hospitals.

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 240 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Aug 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

Hospitalized adult female patients (≥18 years) requiring urinary management for incontinence and who are unable to use standard toileting methods due to limited mobility. Participants are expected to have an inpatient stay of at least 10 days and require use of a urinary collection approach, including indwelling urinary catheters and/or a non-invasive external urinary catheter system, as part of routine clinical care. Subjects will be enrolled from acute care hospital settings across multiple sites in Europe and the Middle East, representing a real-world inpatient population requiring urinary management.

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. Requiring treatment with indwelling urinary catheters or PureWick™ Flex Female External Catheter (PureWick™ FFEC) for urinary management, including urinary incontinence for at least 3 days after enrollment. 3. Has limited mobility and is not able to use sanitary devices that facilitate controlled bladder emptying like bedpans, commode chairs, voiding at the toilet 4. The expected length of stay from enrollment to hospital discharge is at minimum 10 days 5. Willing to comply with all study procedures in this protocol 6. The subject must be willing and able to read, understand, sign, and date the informed consent form. Exclusion Criteria: 1. Clinically confirmed urinary retention. 2. Requiring precise urine output measurement 3. Is known to be pregnant at time of enrollment 4. Has a confirmed diagnosis of a urinary tract infection (UTI), catheter-associated urinary tract infection (CAUTI), or sepsis at the time of the planned indwelling urinary catheter implantation 5. Has documented colonization or infection with multidrug-resistant organisms (MDROs) at the time of the planned indwelling urinary catheter implantation 6. Is agitated, combative, and/or uncooperative and may remove the catheter 7. 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 8. Has any other condition that, in the opinion of the investigator, would preclude them from participating in the study. Additional Exclusion Criteria (Cohort 2 only - PureWick™ FFEC): 9. Has frequent episodes of bowel incontinence without a fecal management system in place 10. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup 11. Has vaginal or other chronic non-urinary tract infections (UTIs), active genital herpes 12. Has any clinically relevant skin condition (e.g. wound, lesion or irritation) affecting the genital, perineal, or sacral area that could interfere with safe and effective device use where is in contact with the device.

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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.

How to take part

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  1. 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 ↗

  2. A doctor treating you

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