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Recruiting NCT04078373

Urinary Disorders in Subacute Patients After Stroke

Observational Stroke, Ischemic Stroke Hemorrhagic Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immediate urination, Bladder diary.
Who it may be relevant to
Registry conditions: Stroke, Ischemic, Stroke Hemorrhagic, Urinary Incontinence. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment and Treatment of Urinary Disorders in Patients in the Subacute Phase After Stroke

Overview

This observational study will address urinary disorders in subacute stroke patients. Patients without and with urinary disorders will be compared, and treatment outcome will be assessed among the latter.

Detailed description

This prospective observational study will include 100 patients after first ischaemic or hemorrhagic stroke directly transferred from an acute hospital to our Institute for inpatient rehabilitation. Within admission assessment, patients will be classified according to stroke type, stroke localisation and time since stroke. Comorbidities will be recorded and associated neurological deficits will be assessed. Post mictional residue will be determined in all patients one day after admission. The patients with urinary disorders will be treated according to the published official protocol, either using the immediate urination approach or the bladder diary approach. Continence will be regularly assessed by the nursing staff. Urination-disorder-related complications (pressure ulcers, falls and urinary infections), drug therapy and the use of continence aids will also be followed.

Interventions

  • Behavioral Immediate urination
    Patients with decreased cognitive ability will be taught to immediately go to the toilet upon feeling the urge to urinate and to be independent in urinating.
  • Behavioral Bladder diary
    Patients with normal cognitive abilities will be instructed to go to the toilet every 2-3 hours regardless of the urge to urinate

Primary outcome measures

  • Degree of urinary continence [Time frame: Through study completion, for an average of 6 weeks]
Secondary outcome measures (1)
  • Presence of urinary-disorders-related complications [Time frame: Through study completion, for an average of 6 weeks]

Eligibility criteria

Inclusion criteria

  • subacute patients after ischaemic or hemorrhagic stroke;
  • direct transfer from acute hospital to complex inpatient rehabilitation at our Institute.

Exclusion criteria

  • incontinence before stroke;
  • previous brain injury or other brain disease;
  • previous bladder or prostate surgery;
  • inability to ambulate before stroke;
  • terminal disease with expected survival less than three months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Slovenia · 1 center
  • University Rehabilitation Institute, Republic of Slovenia — Ljubljana

Identifiers

NCT: NCT04078373 · URIS201901

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗