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Clinical Trials/NCT04078373
NCT04078373
Recruiting
Not Applicable

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

University Rehabilitation Institute, Republic of Slovenia1 site in 1 country250 target enrollmentStarted: June 1, 2019Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
250
Locations
1
Primary Endpoint
Degree of urinary continence

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Degree of urinary continence

Time Frame: Through study completion, for an average of 6 weeks

Urinary continence will be assessed daily by the nursing staff as either complete, partial or incontinence

Secondary Outcomes

  • Presence of urinary-disorders-related complications(Through study completion, for an average of 6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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