Stroke, IschemicUIMKNCT04078373
Urinary Disorders in Subacute Patients After Stroke
An observational study of Stroke, Ischemic and Stroke Hemorrhagic, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Urinary Incontinence
- What is being tested?
- Immediate urination and Bladder diary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2019to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subacute patients after ischaemic or hemorrhagic stroke directly transferred from an acute hospital to complex inpatient rehabilitation
Who may be able to join
- subacute patients after ischaemic or hemorrhagic stroke;
- direct transfer from acute hospital to complex inpatient rehabilitation at our Institute.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
Helena Burger, MD, PhD, +386 1 4758440, helena.burger@ir-rs.si
Nataša Bizovičar, MD, PhD, +386 1 4758351, natasa.bizovicar@ir-rs.si
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Urinary Incontinence
- Being tested
- Immediate urination, Bladder diary
- Keywords
- stroke, inpatient rehabilitation, urinary disorders, treatment
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Urinary Incontinence, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate urinationBehavioural
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 diaryBehavioural
Patients with normal cognitive abilities will be instructed to go to the toilet every 2-3 hours regardless of the urge to urinate
| Study group | Role | What they receive |
|---|---|---|
| Without urinary disorders | Subacute stroke patients without urinary disorders | |
| With urinary disorders | Subacute stroke patients with urinary disorders Receives: Behavioral: Immediate urination; Behavioral: Bladder diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of urinary continence
Urinary continence will be assessed daily by the nursing staff as either complete, partial or incontinence
Measured: Through study completion, for an average of 6 weeks
Secondary outcomes (1)
Presence of urinary-disorders-related complications
Pressure ulcers, falls and urinary infections caused by urinary disorders will be recorded
Measured: Through study completion, for an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jun 2019
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nataša Bizovičar, MD, PhD, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078373
- Sponsor's protocol ID
- URIS201901
- Acronym
- UIMK
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Treatment of Urinary Disorders in Patients in the Subacute Phase After Stroke
- ClinicalTrials.gov ID
- NCT04078373
- Acronym / sponsor ID
- UIMK / URIS201901
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Urinary Incontinence
- Keywords
- stroke, inpatient rehabilitation, urinary disorders, treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without urinary disorders | – | –Subacute stroke patients without urinary disorders |
| With urinary disorders | – | Behavioral: Immediate urination, Behavioral: Bladder diarySubacute stroke patients with urinary disorders |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subacute patients after ischaemic or hemorrhagic stroke directly transferred from an acute hospital to complex inpatient rehabilitation
Key inclusion criteria (2 listed)
- subacute patients after ischaemic or hemorrhagic stroke;
- direct transfer from acute hospital to complex inpatient rehabilitation at our Institute.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate urinationPatients 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. | Behavioural | With urinary disorders |
| Bladder diaryPatients with normal cognitive abilities will be instructed to go to the toilet every 2-3 hours regardless of the urge to urinate | Behavioural | With urinary disorders |
Primary outcome
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
1 secondary outcome
Presence of urinary-disorders-related complications
Time frame: Through study completion, for an average of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke, Ischemic
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nataša Bizovičar, MD, PhD principal investigator
University Rehabilitation Institute, Republic of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Stroke Hemorrhagic, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Burger, MD, PhD (+386 1 4758440, helena.burger@ir-rs.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of urinary continence (time frame: Through study completion, for an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.