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Recruiting NCT07236684

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

Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 30 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Expanded disability status scale (EDSS) [Time frame: Single assessment at enrollment]
  • Neurogenic Bladder Symptom Score (NBSS) [Time frame: Single assessment at enrollment]
  • International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) [Time frame: Single assessment at enrollment]
  • Incontinence Impact Questionnaire (IIQ-7) [Time frame: Single assessment at enrollment]
  • Pelvic Floor Muscle Activity [Time frame: Single assessment at enrollment]
  • International Physical Activity Questionnaire (IPAQ) [Time frame: Single assessment at enrollment]
  • Fatigue severity scale (FSS) [Time frame: Single assessment at enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Prof. Dr. Cemil Taşçıoğlu City Hospital — Istanbul

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT07236684 · EMG MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗