StrokeNCT07048210
Diaphragm Function and Urinary Incontinence in Stroke
An observational study of Stroke, run by Istinye University.
Trial summary
Stroke affects respiratory functions by causing structural and strength impairments in both inspiratory and expiratory respiratory muscles. Weakening of the diaphragm leads to a decrease in maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), which may result in respiratory insufficiency, postural… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 29 Sep 2025
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bahçelievler Medical Park Hospital
Who may be able to join
- Aged between 40 and 75 years,
- Diagnosed with hemorrhagic or ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) conducted by a specialist physician,
- Presence of urinary incontinence,
- No other orthopedic, rheumatologic, or neurological diagnoses apart from stroke,
- Ability to understand the investigator's instructions and a score of ≥24 on the Mini-Mental State Examination (MMSE),
- Voluntary participation in the study,
- Ability to speak and understand Turkish.
Who cannot join
- Presence of serious diseases affecting vital organs such as the heart, lungs, liver, or kidneys,
- Presence of a genitourinary infection,
- Pelvic organ prolapse at stage 3 or higher,
- Uncontrolled cardiopulmonary or unstable chronic diseases,
- Presence of one or more neurological disorders that may cause balance impairments,
- Severe cognitive, speech, or visual impairments,
- History of urogynecological surgery within the past 6 months,
- History of abdominal surgery within the past 6 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Relationship Between Diaphragm Muscle Function and Urinary Incontinence in Stroke Patients
Stroke affects respiratory functions by causing structural and strength impairments in both inspiratory and expiratory respiratory muscles. Weakening of the diaphragm leads to a decrease in maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), which may result in respiratory insufficiency, postural instability, and urinary incontinence (UI). Additionally, post-stroke reduction in diaphragmatic mobility and decreased activity of the diaphragm and abdominal muscles on the paretic side may disrupt the piston mechanism between the diaphragm and pelvic floor muscles. These mechanical changes may trigger the development of urinary incontinence. This study aims to investigate the relationship between diaphragm muscle strength and endurance and urinary incontinence in 50 stroke patients. In addition, diaphragmatic function and posture-related respiratory changes will be evaluated using functional tests based on the Dynamic Neuromuscular Stabilization (DNS) approach. The relationship between respiratory muscle strength (MIP, MEP) and endurance and the scores of the Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7) will be analyzed. Furthermore, individuals with and without urinary incontinence symptoms will be evaluated in terms of diaphragmatic function and contribution to respiration.
- Conditions
- Stroke
- Keywords
- Diaphragm, Urinary Incontinence, Stroke, Respiratory Function
- Medical subject headings
- Stroke, Urinary Incontinence, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Patients | 50 individuals diagnosed with stroke will undergo assessments of diaphragmatic function, respiratory muscle strength and endurance, and urinary incontinence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Muscle Function
Diaphragm muscle function will be assessed using the Dynamic Neuromuscular Stabilization (DNS) approach. The evaluation consists of three components: (1) the diaphragm's contribution to respiration, (2) its role in postural stabilization, and (3) active respiration during postural stabilization. Each component will be rated separately using a 4-point scale: none (3), mild (2), moderate (1), and severe (0). Higher total scores reflect greater impairment in diaphragm-related respiratory function.
Measured: Baseline (single assessment)
Urogenital Distress Inventory (UDI-6)
The Urogenital Distress Inventory (UDI-6) consists of 6 items and is rated on a four-point Likert scale. The total score ranges from 0 to 18, with higher scores indicating greater symptom distress and a more impaired quality of life.
Measured: Baseline (single assessment)
Incontinence Impact Questionnaire (IIQ-7)
The Incontinence Impact Questionnaire (IIQ-7) consists of 7 items and is rated on a four-point Likert scale. The total score ranges from 0 to 21, with lower scores indicating less impact on quality of life.
Measured: Baseline (single assessment)
Secondary outcomes (2)
Respiratory Muscle Strength
Respiratory muscle strength will be assessed using a portable device capable of measuring maximal inspiratory (MIP) and expiratory (MEP) mouth pressures electronically (MicroRPM, Micro Medical, Kent, UK). Measurements will be conducted with the participant in a seated position, wearing a nose clip to prevent air leakage. For MIP, the participant will perform a maximal exhalation followed by a maximal inhalation against an occluded airway for at least 1.5 seconds. For MEP, a maximal inhalation will be followed by a maximal exhalation under the same conditions. Each measurement will be repeated three times with less than 10% variability, and the highest value will be used for analysis.
Measured: Baseline (single assessment)
Respiratory Muscle Endurance
Respiratory muscle endurance will be assessed using a threshold loading test with the PowerBreathe device (HaB International Ltd., Southam, UK). The test will begin at 20% of the participant's maximal inspiratory pressure (MIP) and will be increased in two-minute intervals to 40%, 60%, 80%, and finally 100% of MIP. During the test, the device will be placed in the participant's mouth and a nose clip will be used to prevent nasal breathing. Participants will be instructed to breathe through the mouth for 10 minutes. Oxygen saturation and perceived dyspnea will be measured before the test, at the end of each two-minute stage, and after the test. Test results will be calculated by multiplying the total test duration by the corresponding pressure level at each stage.
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start30 Jun 2025 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion29 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048210
- Sponsor's protocol ID
- IstinyeUni-STROKE-2025
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
Publications
Zachovajeviene B, Siupsinskas L, Zachovajevas P, Venclovas Z, Milonas D. Effect of diaphragm and abdominal muscle training on pelvic floor strength and endurance: results of a prospective randomized trial. Sci Rep. 2019 Dec 16;9(1):19192. doi: 10.1038/s41598-019-55724-4.
PubMed 31844133Kobesova A, Davidek P, Morris CE, Andel R, Maxwell M, Oplatkova L, Safarova M, Kumagai K, Kolar P. Functional postural-stabilization tests according to Dynamic Neuromuscular Stabilization approach: Proposal of novel examination protocol. J Bodyw Mov Ther. 2020 Jul;24(3):84-95. doi: 10.1016/j.jbmt.2020.01.009. Epub 2020 Feb 8.
PubMed 32826013Tutuneken YE, Cakmak O, Demir B, Yildirim SY, Anlar E, Ozkul ME. Relationship between diaphragmatic muscle function and urinary incontinence in individuals with stroke: a prospective observational study. Top Stroke Rehabil. 2026 Feb 18:1-10. doi: 10.1080/10749357.2026.2634288. Online ahead of print.
PubMed 41704224
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Diaphragm Muscle Function and Urinary Incontinence in Stroke Patients
- ClinicalTrials.gov ID
- NCT07048210
- Acronym / sponsor ID
- IstinyeUni-STROKE-2025
- Conditions
- Stroke
- Keywords
- Diaphragm, Urinary Incontinence, Stroke, Respiratory Function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 29 Sep 2025 (estimated)
- First posted
- 2 Jul 2025 (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.
Stroke affects respiratory functions by causing structural and strength impairments in both inspiratory and expiratory respiratory muscles. Weakening of the diaphragm leads to a decrease in maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), which may result in respiratory insufficiency, postural instability, and urinary incontinence (UI). Additionally, post-stroke reduction in diaphragmatic mobility and decreased activity of the diaphragm and abdominal muscles on the paretic side may disrupt the piston mechanism between the diaphragm and pelvic floor muscles. These mechanical changes may trigger the development of urinary incontinence. This study aims to investigate the relationship between diaphragm muscle strength and endurance and urinary incontinence in 50 stroke patients. In addition, diaphragmatic function and posture-related respiratory changes will be evaluated using functional tests based on the Dynamic Neuromuscular Stabilization (DNS) approach. The relationship between respiratory muscle strength (MIP, MEP) and endurance and the scores of the Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7) will be analyzed. Furthermore, individuals with and without urinary incontinence symptoms will be evaluated in terms of diaphragmatic function and contribution to respiration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients | – | –50 individuals diagnosed with stroke will undergo assessments of diaphragmatic function, respiratory muscle strength and endurance, and urinary incontinence. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bahçelievler Medical Park Hospital
Key inclusion criteria (7 listed)
- Aged between 40 and 75 years,
- Diagnosed with hemorrhagic or ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) conducted by a specialist physician,
- Presence of urinary incontinence,
- No other orthopedic, rheumatologic, or neurological diagnoses apart from stroke,
- Ability to understand the investigator's instructions and a score of ≥24 on the Mini-Mental State Examination (MMSE),
Key exclusion criteria (8 listed)
- Presence of serious diseases affecting vital organs such as the heart, lungs, liver, or kidneys,
- Presence of a genitourinary infection,
- Pelvic organ prolapse at stage 3 or higher,
- Uncontrolled cardiopulmonary or unstable chronic diseases,
- Presence of one or more neurological disorders that may cause balance impairments,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diaphragm Muscle Function
Time frame: Baseline (single assessment)
Diaphragm muscle function will be assessed using the Dynamic Neuromuscular Stabilization (DNS) approach. The evaluation consists of three components: (1) the diaphragm's contribution to respiration, (2) its role in postural stabilization, and (3) active respiration during postural stabilization. Each component will be rated separately using a 4-point scale: none (3), mild (2), moderate (1), and severe (0). Higher total scores reflect greater impairment in diaphragm-related respiratory function.
Urogenital Distress Inventory (UDI-6)
Time frame: Baseline (single assessment)
The Urogenital Distress Inventory (UDI-6) consists of 6 items and is rated on a four-point Likert scale. The total score ranges from 0 to 18, with higher scores indicating greater symptom distress and a more impaired quality of life.
Incontinence Impact Questionnaire (IIQ-7)
Time frame: Baseline (single assessment)
The Incontinence Impact Questionnaire (IIQ-7) consists of 7 items and is rated on a four-point Likert scale. The total score ranges from 0 to 21, with lower scores indicating less impact on quality of life.
2 secondary outcomes
Respiratory Muscle Strength
Time frame: Baseline (single assessment)
Respiratory Muscle Endurance
Time frame: Baseline (single assessment)
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 2 Jul 2025.
- Background: PubMed 31844133Zachovajeviene B, Siupsinskas L, Zachovajevas P, Venclovas Z, Milonas D. Effect of diaphragm and abdominal muscle training on pelvic floor strength and endurance: results of a prospective randomized trial. Sci Rep. 2019 Dec 16;9(1):19192. doi: 10.1038/s41598-019-55724-4.
- Background: PubMed 32826013Kobesova A, Davidek P, Morris CE, Andel R, Maxwell M, Oplatkova L, Safarova M, Kumagai K, Kolar P. Functional postural-stabilization tests according to Dynamic Neuromuscular Stabilization approach: Proposal of novel examination protocol. J Bodyw Mov Ther. 2020 Jul;24(3):84-95. doi: 10.1016/j.jbmt.2020.01.009. Epub 2020 Feb 8.
- Derived from this study: PubMed 41704224Tutuneken YE, Cakmak O, Demir B, Yildirim SY, Anlar E, Ozkul ME. Relationship between diaphragmatic muscle function and urinary incontinence in individuals with stroke: a prospective observational study. Top Stroke Rehabil. 2026 Feb 18:1-10. doi: 10.1080/10749357.2026.2634288. Online ahead of print.
- Individual participant dataSharing planned: Yes. The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses. These data will be provided to support transparency and allow for interpretation of the study findings.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Istinye University.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Özge Çakmak, MSc (+905359463069, ozgeckmakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Muscle Function (time frame: Baseline (single assessment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048210, which also lists 3 linked publications.
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 2 Jul 2025.