Urinary Disorders in Subacute Patients After Stroke (UIMK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Stroke, Ischemic; Stroke Hemorrhagic
• Intervention / Treatment: Behavioral: Immediate urination; Behavioral: Bladder diary

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Helena Burger, MD, PhD; Phone Number: +386 1 4758440; Email: helena.burger@ir-rs.si
• Study Contact Backup: Name: Nataša Bizovičar, MD, PhD; Phone Number: +386 1 4758361; Email: natasa.bizovicar@ir-rs.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Rehabilitation Institute, Republic of Slovenia
    • Contact: Helena Burger, MD, PhD; Phone Number: +386 1 4758440; Email: helena.burger@ir-rs.si
    • Contact: Nataša Bizovičar, MD, PhD; Phone Number: +386 1 4758351; Email: natasa.bizovicar@ir-rs.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Without urinary disorders; Subacute stroke patients without urinary disorders
With urinary disorders; Subacute stroke patients with urinary disorders	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Nataša Bizovičar, MD, PhD, University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 31, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: treatment; stroke; urinary disorders; inpatient rehabilitation
• Additional Relevant MeSH Terms: Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Ischemic Stroke; Hemorrhagic Stroke; Stroke; Urinary Incontinence
• Other Study ID Numbers: URIS201901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No