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RecruitingNCT04078373UIMKUpdated Jun 15, 2026

Urinary Disorders in Subacute Patients After Stroke

An observational study in Stroke, Ischemic, Stroke Hemorrhagic and Urinary Incontinence, sponsored by University Rehabilitation Institute, Republic of Slovenia. Recruiting at 1 site in Slovenia. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University Rehabilitation Institute, Republic of Slovenia · Observational

From the registry’s dates

  • Started Jun 2019; still recruiting 7 years 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
250
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke, Ischemic
  • Stroke Hemorrhagic
  • Urinary Incontinence

Keywords

  • stroke
  • inpatient rehabilitation
  • urinary disorders
  • treatment
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 250 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralImmediate 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.

  • BehavioralBladder diary

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

06

What researchers measure

Primary outcomes

  1. Degree of urinary continence

    Urinary continence will be assessed daily by the nursing staff as either complete, partial or incontinence

    Time frame: 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

    Time frame: Through study completion, for an average of 6 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2019 (actual). Primary completion is estimated for Oct 2026, 88 months after the start.

Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 88 months is above that.

Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2019
First posted
Sep 6, 2019
StartActual
Jun 1, 2019
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2026
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04078373
Lead sponsor
University Rehabilitation Institute, Republic of Slovenia
Responsible party
Sponsor
First posted
Sep 6, 2019
Start date
Jun 1, 2019
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Helena Burger, MD, PhD
Contact
helena.burger@ir-rs.si
+386 1 4758440
Nataša Bizovičar, MD, PhD
Contact
natasa.bizovicar@ir-rs.si
+386 1 4758361
Nataša Bizovičar, MD, PhD
principal investigator · University Rehabilitation Institute, Republic of Slovenia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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