Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07048210

Diaphragm Function and Urinary Incontinence in Stroke

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Respiratory Muscle Strength

    Time frame: Baseline (single assessment)

    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.

  2. Respiratory Muscle Endurance

    Time frame: Baseline (single assessment)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunus Emre Tütüneken

CONTACT

[email protected]

+905435912455

Özge Çakmak, MSc

CONTACT

[email protected]

+905359463069

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Investigation of the Relationship Between Diaphragm Muscle Function and Urinary Incontinence in Stroke Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.