Diaphragm Function and Urinary Incontinence in Stroke

NCT ID: NCT07048210

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-09-29

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke Patients

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Özge Çakmak, MSc

Role: CONTACT

ozgeckmakk@gmail.com

+905359463069

Yunus Emre Tütüneken

Role: CONTACT

yunus.tutuneken@istinye.edu.tr

+905435912455

References

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.

Reference Type: BACKGROUND

PMID: 31844133 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32826013 (View on PubMed)

Other Identifiers

IstinyeUni-STROKE-2025

Identifier Type: -

Identifier Source: org_study_id