StrokeNCT06333119
The Relationship Between Urinary Incontinence and Motor Symptoms
An observational study of Stroke and Urinary Incontinence, run by Pinar Yasar at 1 site in Turkey (Türkiye).
Trial summary
There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Urinary Incontinence, Motor Skills Disorders
- What is being tested?
- modified rankin scale
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals with stroke
Who may be able to join
- Being 18 years old, having a stroke history of at least 3 months, having had only one stroke, scoring between 0-2 points according to MRS, being able to stand and walk independently or with a walking aid, being able to speak Turkish.
Who cannot join
- Those with incomprehensible speech disorders,
- Those who have additional neurological diseases other than stroke,
- orthopedic, cardiovascular, etc., which may cause balance disorders. those with illnesses,
- those who are pregnant,
- Those with vision and hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Urinary Incontinence and Motor Symptoms in Individuals With Stroke
There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke.
Read the detailed description
Evaluation parameters used in the study:
Modified Rankin Score 24 hours pad test Tinetti Balance and Gait Scale Modified Ashworth scale Danish Prostatic Symptom Score
- Conditions
- Stroke, Urinary Incontinence, Motor Skills Disorders
- Being tested
- modified rankin scale
- Keywords
- stroke, urinary incontinence, spasticity, balance, gait
- Medical subject headings
- Stroke, Urinary Incontinence, Motor Skills Disorders, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified rankin scaleDiagnostic test
Also called modified ashworth scale, Tinetti Balance and Gait Scale, Danish Prostatic Symptom Score
Modified Rankin Scale: The functional status of individuals with stroke is determined by this scale.
Modified Ashworth Scale: It allows determining the severity of spasticity. Tinetti Balance and Gait Scale: This scale helps determine the risk of falling by evaluating balance and gait.
Danish Prostatic Symptom Score: It allows to evaluate the storage and urinary functions of the bladder.
| Study group | Role | What they receive |
|---|---|---|
| individuals with stroke | Not described Receives: Diagnostic Test: modified rankin scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship with between urinary incontinence and motor symptoms
correlation analysis was done.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Sep 2023
- Primary completion31 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinar Yasar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pinar Yasar, Suleyman Demirel University
- Investigators
- Pinar Yasar, Study director, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333119
- Sponsor's protocol ID
- 72867572-050.01.04-320
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was decided not to share the data, taking into account the personal data protection law.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Urinary Incontinence and Motor Symptoms in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT06333119
- Acronym / sponsor ID
- 72867572-050.01.04-320
- Conditions
- Stroke, Urinary Incontinence, Motor Skills Disorders
- Keywords
- stroke, urinary incontinence, spasticity, balance, gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pinar YasarUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 27 Mar 2024 (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.
There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke.
Detailed description
Evaluation parameters used in the study:
Modified Rankin Score 24 hours pad test Tinetti Balance and Gait Scale Modified Ashworth scale Danish Prostatic Symptom Score
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| individuals with stroke | – | Diagnostic Test: modified rankin scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with stroke
Key inclusion criteria (1 listed)
- Being 18 years old, having a stroke history of at least 3 months, having had only one stroke, scoring between 0-2 points according to MRS, being able to stand and walk independently or with a walking aid, being able to speak Turkish.
Key exclusion criteria (5 listed)
- Those with incomprehensible speech disorders,
- Those who have additional neurological diseases other than stroke,
- orthopedic, cardiovascular, etc., which may cause balance disorders. those with illnesses,
- those who are pregnant,
- Those with vision and hearing loss
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 |
|---|---|---|
| modified rankin scaleAlso: modified ashworth scale, Tinetti Balance and Gait Scale, Danish Prostatic Symptom ScoreModified Rankin Scale: The functional status of individuals with stroke is determined by this scale. Modified Ashworth Scale: It allows determining the severity of spasticity. Tinetti Balance and Gait Scale: This scale helps determine the risk of falling by evaluating balance and gait. Danish Prostatic Symptom Score: It allows to evaluate the storage and urinary functions of the bladder. | Diagnostic test | individuals with stroke |
Primary outcome
relationship with between urinary incontinence and motor symptoms
Time frame: 4 months
correlation analysis was done.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No. It was decided not to share the data, taking into account the personal data protection law.
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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. This study is not recruiting at the moment.
Pinar Yasar study director
Suleyman Demirel University
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 and Urinary Incontinence, run by Pinar Yasar at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 27 Mar 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship with between urinary incontinence and motor symptoms (time frame: 4 months). 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 27 Mar 2024.