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NCT Number: NCT07236684

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

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.

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Key information

About this study

The study will consist of a cross-sectional observational analysis involving a cohort of 47 PwMS. The assessment will be employed various instruments, including the Expanded Disability Status Scale (EDSS), Neurogenic Bladder Symptom Score (NBSS), International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Impact Questionnaire (IIQ-7), International Physical Activity Questionnaire (IPAQ), Fatigue Severity Scale (FSS), EMG.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Expanded disability status scale (EDSS)

    Time frame: Single assessment at enrollment

    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.

  2. Neurogenic Bladder Symptom Score (NBSS)

    Time frame: Single assessment at enrollment

    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.

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

    Time frame: Single assessment at enrollment

    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.

  4. Incontinence Impact Questionnaire (IIQ-7)

    Time frame: Single assessment at enrollment

    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.

  5. Pelvic Floor Muscle Activity

    Time frame: Single assessment at enrollment

    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.

  6. International Physical Activity Questionnaire (IPAQ)

    Time frame: Single assessment at enrollment

    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.

  7. Fatigue severity scale (FSS)

    Time frame: Single assessment at enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep Yıldız Kızkın

CONTACT

[email protected]

5346945085 ext. +90

Sponsors and collaborators

Lead sponsor

Artvin Coruh University

Other

Registry information

Official study title

Identification of Factors Related to Urinary Incontinence in Patients With Multiple Sclerosis and Electromyographic Assessment of Pelvic Floor Muscle Activity: A Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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