Delirium Incidence and Indwelling Urinary CathEterization After Acute Stroke (DICES)

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.

Study Overview

• Status: Terminated
• Conditions: Post-Stroke Delirium
• Intervention / Treatment: Device: condom catheter

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany
    • University Medicine Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care (IUC)
Active Comparator: condom catheter	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 days after admission

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Annerose Mengel, MD, Universitätsklnikum Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 144/2021BO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No