An interventional study of condom catheter in Post-Stroke Delirium, sponsored by University Hospital Tuebingen. Terminated at 1 site in Germany. Open to male participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Prevention
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.
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.
University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
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Inclusion Criteria:
Inclusion Criteria
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:
Device: condom catheter
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
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
Time frame: 10 days after admission
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen