New catheter design tested for gentler bladder impact
NCT ID NCT05224544
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new prototype catheter with micro holes against a standard two-eyelet catheter in 43 healthy women. Researchers looked at changes in the bladder lining right after catheter use. The goal was to see if the new design causes less irritation, helping improve future catheter comfort.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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43 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Mar 2022
- 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.
- Ages
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18 to 110 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Has given written informed consent 2. Is at least 18 years and have full legal capacity 3. Is female 4. Has a negative urine Multistix dipstick test for erythrocytes (haematuria) Exclusion Criteria: 1. Has used an internal urinary catheter or cystoscopy within the past month 2. Has prior history of bladder surgery 3. Is symptomatic and/or on medication for overactive bladder 4. Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate) 5. Is pregnant and/or breast-feeding 6. Is participating in other clinical investigations during this investigation 7. Is menstruating during study period
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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.
Contacts and locations
Locations
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American Health Research
Charlotte, North Carolina, 28277, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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