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Diaphragm Function and Urinary Incontinence in Stroke

I

Istinye University

Status

Not yet enrolling

Conditions

Stroke

Study type

Observational

Funder types

Other

Identifiers

NCT07048210
IstinyeUni-STROKE-2025

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Stroke Patients
Description:
50 individuals diagnosed with stroke will undergo assessments of diaphragmatic function, respiratory muscle strength and endurance, and urinary incontinence.

Trial contacts and locations

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Central trial contact

Yunus Emre Tütüneken; Özge Çakmak, MSc

Data sourced from clinicaltrials.gov

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