Urinary Disorders in Subacute Patients After Stroke

NCT04078373 | Recruiting

• 1 other identifier: URIS201901
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic; Urinary Incontinence

Keywords

stroke; inpatient rehabilitation; urinary disorders; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Presence of urinary-disorders-related complications

  Through study completion, for an average of 6 weeks

Study Arms (2)

Without urinary disorders

Subacute stroke patients without urinary disorders

With urinary disorders

Subacute stroke patients with urinary disorders

Behavioral: Immediate urination; Behavioral: Bladder diary

Interventions

Immediate urination 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.

With urinary disorders

Bladder diary BEHAVIORAL

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

With urinary disorders

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subacute patients after ischaemic or hemorrhagic stroke directly transferred from an acute hospital to complex inpatient rehabilitation

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Urinary Incontinence; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nataša Bizovičar, MD, PhD

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Burger, MD, PhD

CONTACT

+386 1 4758440; helena.burger@ir-rs.si

Nataša Bizovičar, MD, PhD

CONTACT

+386 1 4758361; natasa.bizovicar@ir-rs.si

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: June 1, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)