A gentler catheter may cut infection risk for women in hospitals
NCT ID NCT07798128
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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