Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity

NCT07236684 | Recruiting

• 1 other identifier: EMG MS
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to explore the link between urinary incontinence (UI) severity in patients with multiple sclerosis (PwMS), electromyography (EMG) findings, and other relevant factors.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; electromyography; urinary incontinence; pelvic floor; fatigue

Outcome Measures

Primary Outcomes (7)

• Expanded disability status scale (EDSS)

  The Expanded disability status scale (EDSS) will be assessed disability and progression in PwMS, with scores from 0 (normal neurological exam) to 10 (death from MS). Higher scores indicate greater disability.

  Single assessment at enrollment

• Neurogenic Bladder Symptom Score (NBSS)

  Storage, voiding, and complication symptoms of neurogenic bladder will be assessed with the Neurogenic Bladder Symptom Score (NBSS), a 24-item questionnaire covering incontinence, storage and voiding, and outcomes.

  Single assessment at enrollment

• International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

  The frequency and amount of leakage will be assessed using a six-item scale, and urinary incontinence will be categorised into four groups: mild (1-5), moderate (6-12), severe (13-18) and very severe.

  Single assessment at enrollment

• Incontinence Impact Questionnaire (IIQ-7)

  Urinary symptoms' impact on daily activities was assessed with the Incontinence Impact Questionnaire (IIQ-7). The 7-item Likert scale has a score range of 0-21, with higher scores reflecting an increased negative impact of incontinence on social functioning, quality of life, and physical activity.

  Single assessment at enrollment

• Pelvic Floor Muscle Activity

  An electromyography (EMG) device with surface electrodes will be used to assess pelvic floor muscle (PFM) activity. Patients received training beforehand, and measurements were taken noninvasively with two electrodes around the perineum and vagina and one on the inner thigh in women.

  Single assessment at enrollment

• International Physical Activity Questionnaire (IPAQ)

  The International Physical Activity Questionnaire (IPAQ) assesses the frequency and duration of vigorous, moderate, and walking-like activities over a week. The values are multiplied by factors of 8, 4, and 3.3 Metabolic Equivalent of Tasks, respectively, to help measure overall physical activity. The minimum score for the IPAQ is 0, while there is no theoretically determined maximum score. Higher scores are associated with the individual engaging in a higher level of physical activity.

  Single assessment at enrollment

• Fatigue severity scale (FSS)

  Fatigue severity scale (FSS) assesses fatigue severity in MS with nine items rated on a 7-point Likert scale. The mean score, adapted to Turkish society, indicates pathological fatigue if it is 4 or higher.

  Single assessment at enrollment

Study Arms (1)

Patients with Multiple Sclerosis (PwMS)

Adults diagnosed with multiple sclerosis will be included in the study.

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Only women with MS will be included.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with MS will be included in the study.

You may qualify if:

• having an MS diagnosis according to the 2017 revised McDonald criteria,
• experiencing symptoms of UI as defined by the International Continence Society (ICS),
• having an EDSS score below 6.5,
• PwMS with no communication issues.

You may not qualify if:

• PwMS who did not give consent to participate,
• those with medication changes in the past 6 months,
• pregnant PwMS,
• recent vaginal or caesarean deliveries within 6 months,
• pelvic organ prolapse,
• urinary tract infection,
• recent attack history in the past month.

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Zecca C, Riccitelli GC, Disanto G, Singh A, Digesu GA, Panicari L, Puccini F, Mattioli M, Tubaro A, Gobbi C. Urinary incontinence in multiple sclerosis: prevalence, severity and impact on patients' quality of life. Eur J Neurol. 2016 Jul;23(7):1228-34. doi: 10.1111/ene.13010. Epub 2016 Apr 27.

  PMID: 27120000 BACKGROUND

• Tornic J, Panicker JN. The Management of Lower Urinary Tract Dysfunction in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2018 Jun 28;18(8):54. doi: 10.1007/s11910-018-0857-z.

  PMID: 29956001 BACKGROUND

• Afshari P, Abedi P, Majdinasab N, Tafakh S, Haghighizadeh M. Strengths of pelvic floor muscles in women with multiple sclerosis and its relationship with urinary incontinence and quality of life. Front Neurol. 2025 Jan 13;15:1514157. doi: 10.3389/fneur.2024.1514157. eCollection 2024.

  PMID: 39871990 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Incontinence; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System 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

Study Officials

• Zeynep Yıldız Kızkın

  Artvin Coruh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Yıldız Kızkın

CONTACT

5346945085; pt.zeynepyildiz@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)