Could a simple switch in catheters prevent post-stroke delirium?
NCT ID NCT07264244
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether using a condom catheter instead of a standard indwelling urinary catheter (IUC) lowers the chance of delirium in men aged 70+ who had a stroke. Delirium is a sudden confused state that can happen after a stroke. The trial planned to compare two groups, but it was stopped early, so the results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- condom catheter
- What this could lead to
- If successful, this could point toward a simple change in hospital practice to lower delirium rates in older male stroke patients.
- What could go wrong
- The study was terminated early with only 50 participants, so results may be inconclusive. It only included men over 70, so findings may not apply to others.
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
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50 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Mar 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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70 years and older
- Sex
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Male 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion Criteria * Male gender * Age ≥ 70 years * Treated with recanalization therapy and therefore receiving an IUC * Patient is able to provide written informed consent. If patient is aphasic and not in a position to provide written informed consent after the stroke, a relative or a legal guardian can provide information of the presumed will of the patient. Inclusion of this patient is possible if the patient will give basic informed consent as soon as he is able to and after a maximum of seven days after enrollment. As delirium is associated with stroke severity it is necessary to include these patients, otherwise the incidence of delirium will be too low. Exclusion Criteria: * Delirium at admission * Need for mechanical ventilation \> 48h * Presence of an IUC before admission
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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
-
University Medicine Tuebingen
Tübingen, Germany
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Other studies related to the condition(s) this trial covers.
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