Urinary Disorders in Subacute Patients After Stroke

Urinary Incontinence Clinical Trial

— UIMK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04078373
• Other study ID #: URIS201901
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: Helena Burger, MD, PhD
• Phone: +386 1 4758440
• Email: helena.burger[@]ir-rs.si
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic
• Urinary Incontinence

Intervention

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.
• 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

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of urinary continence	Urinary continence will be assessed daily by the nursing staff as either complete, partial or incontinence	Through study completion, for an average of 6 weeks
Secondary	Presence of urinary-disorders-related complications	Pressure ulcers, falls and urinary infections caused by urinary disorders will be recorded	Through study completion, for an average of 6 weeks