Post-Stroke DeliriumDICESNCT07264244
Delirium Incidence and Indwelling Urinary CathEterization After Acute Stroke
A study testing condom catheter in people with Post-Stroke Delirium, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients. Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Post-Stroke Delirium
- What is being tested?
- condom catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Delirium at admission
- Need for mechanical ventilation > 48h
- Presence of an IUC before admission
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients.
Read the detailed description
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients. With a prospective randomized-controlled interventional study design it aims to provide reliable evidence to effectively reduce delirium as well as secondary complications after IUC in critically ill patients. Until now, male, severely affected acute stroke patients regularly receive IUC for recanalization therapy or to balance fluid intake. Complications might be urinary infections, agitation and accidental removal by the patient himself with urinary bleeding.
We ought to investigate if early removal of the IUC after recanalization therapy and replacement with either a condom catheter or a diaper might reduce complications after catheterization and hereby reduce delirium.
As a secondary outcome we would like to explore other options besides indwelling urinary catheterization for balancing the fluid in- and output.
- Conditions
- Post-Stroke Delirium
- Being tested
- condom catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
condom catheterDevice
The subjects will be randomly assigned to one of two groups. The subjects in the control group will receive as part of our ongoing clinical routine an IUC at the time of admission. For IUC a well established standard operating procedure in our clinic will be followed (https://vswroxtra01.ukt.ad.local/Roxtra/index.aspx: Legen eines transurethralen Blasenkatheters (BLK). The intervention group will be provided a condom catheter. If necessary, the ladder will be assisted with a urine bottle or a toilet chair
| Study group | Role | What they receive |
|---|---|---|
| usual care (IUC) | No intervention | Not described |
| condom catheter | Active comparator | Not described Receives: Device: condom catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
The primary outcome will be the development of delirium within 10 days after admission.
Secondary outcomes will be
- Length of stay on NICU / stroke unit
- Development of UTI
- Development of neurological bladder dysfunction
- Pleura effusions and/or ankle edema
Measured: 10 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2023
Why it stopped: all participants recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised open label trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annerose Mengel, MD, Principal investigator, Universitätsklnikum Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264244
- Sponsor's protocol ID
- 144/2021BO1
- Acronym
- DICES
- Status last verified
- Mar 2021
- First submitted
- 6 Apr 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium Incidence and Indwelling Urinary CathEterization After Acute Stroke
- ClinicalTrials.gov ID
- NCT07264244
- Acronym / sponsor ID
- DICES / 144/2021BO1
- Conditions
- Post-Stroke Delirium
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: all participants recruited
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients.
Detailed description
The main goal of this study is to identify indwelling urinary catheterization (IUC) as a predictive factor of the development of delirium in male acute stroke patients. With a prospective randomized-controlled interventional study design it aims to provide reliable evidence to effectively reduce delirium as well as secondary complications after IUC in critically ill patients. Until now, male, severely affected acute stroke patients regularly receive IUC for recanalization therapy or to balance fluid intake. Complications might be urinary infections, agitation and accidental removal by the patient himself with urinary bleeding.
We ought to investigate if early removal of the IUC after recanalization therapy and replacement with either a condom catheter or a diaper might reduce complications after catheterization and hereby reduce delirium.
As a secondary outcome we would like to explore other options besides indwelling urinary catheterization for balancing the fluid in- and output.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised open label trial
| Arm | Type | Receives |
|---|---|---|
| usual care (IUC) | No intervention | – |
| condom catheter | Active comparator | Device: condom catheter |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Delirium at admission
- Need for mechanical ventilation > 48h
- Presence of an IUC before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| condom catheterThe subjects will be randomly assigned to one of two groups. The subjects in the control group will receive as part of our ongoing clinical routine an IUC at the time of admission. For IUC a well established standard operating procedure in our clinic will be followed (https://vswroxtra01.ukt.ad.local/Roxtra/index.aspx: Legen eines transurethralen Blasenkatheters (BLK). The intervention group will be provided a condom catheter. If necessary, the ladder will be assisted with a urine bottle or a toilet chair | Device | condom catheter |
Primary outcome
Delirium
Time frame: 10 days after admission
The primary outcome will be the development of delirium within 10 days after admission. Secondary outcomes will be * Length of stay on NICU / stroke unit * Development of UTI * Development of neurological bladder dysfunction * Pleura effusions and/or ankle edema
Results and safety
The study was stopped early (reason given: all participants recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annerose Mengel, MD principal investigator
Universitätsklnikum Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing condom catheter in people with Post-Stroke Delirium, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: all participants recruited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: 10 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.