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NCT07048210Not yet recruiting

Diaphragm Function and Urinary Incontinence in Stroke

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

Source: ClinicalTrials.gov · Last updated 2 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
24 Jun 2025
Start date
30 Jun 2025
Primary completion date
25 Aug 2025
Lead sponsor
Istinye University
Diseases
Stroke
NCT number
NCT07048210

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 30 Jun 2025 to the primary completion date, 25 Aug 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of serious diseases affecting vital organs such as the heart, lungs, liver, or kidneys,
  • Presence of a genitourinary infection,
  • Uncontrolled cardiopulmonary or unstable chronic diseases,
  • Presence of one or more neurological disorders that may cause balance impairments,
  • History of urogynecological surgery within the past 6 months,
  • History of abdominal surgery within the past 6 months.

Other

  • Pelvic organ prolapse at stage 3 or higher,
  • Severe cognitive, speech, or visual impairments,

Who the study is looking for

  • 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.

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.