Diaphragm Function and Urinary Incontinence in Stroke

NCT07048210 | Not Yet Recruiting

• 1 other identifier: IstinyeUni-STROKE-2025
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline (single assessment)

Secondary Outcomes (2)

• Respiratory Muscle Strength

  Baseline (single assessment)

• Respiratory Muscle Endurance

  Baseline (single assessment)

Study Arms (1)

Stroke Patients

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

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bahçelievler Medical Park Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Related Publications (2)

• 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.

  PMID: 31844133 BACKGROUND

• Kobesova 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.

  PMID: 32826013 BACKGROUND

MeSH Terms

Conditions

Stroke; Urinary Incontinence; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Özge Çakmak, MSc

CONTACT

+905359463069; ozgeckmakk@gmail.com

Yunus Emre Tütüneken

CONTACT

+905435912455; yunus.tutuneken@istinye.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: June 30, 2025
• Primary Completion: August 25, 2025
• Study Completion: September 29, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Summary-level data and supporting documents (e.g., study protocol and statistical analysis plan) will be available within 12 months following the final publication of study results and will remain accessible for at least 5 years via institutional repository or upon reasonable request.