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Urinary Disorders in Subacute Patients After Stroke

NCT ID: NCT04078373

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Stroke, Ischemic Stroke Hemorrhagic Urinary Incontinence

Keywords

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stroke inpatient rehabilitation urinary disorders treatment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Without urinary disorders

Subacute stroke patients without urinary disorders

No interventions assigned to this group

With urinary disorders

Subacute stroke patients with urinary disorders

Immediate urination

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Patients with normal cognitive abilities will be instructed to go to the toilet every 2-3 hours regardless of the urge to urinate

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nataša Bizovičar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Rehabilitation Institute, Republic of Slovenia

Locations

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University Rehabilitation Institute, Republic of Slovenia

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Helena Burger, MD, PhD

Role: CONTACT

Phone: +386 1 4758440

Email: [email protected]

Nataša Bizovičar, MD, PhD

Role: CONTACT

Phone: +386 1 4758361

Email: [email protected]

Facility Contacts

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Helena Burger, MD, PhD

Role: primary

Nataša Bizovičar, MD, PhD

Role: backup

Other Identifiers

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URIS201901

Identifier Type: -

Identifier Source: org_study_id