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NCT Number: NCT07489794

URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS

This study aims to investigate the relationship between urinary incontinence severity and surface electromyography (EMG) findings in women with multiple sclerosis. It will also examine the association of urinary incontinence with disability, quality of life, physical activity, and fatigue.

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Key information

About this study

This study investigates the relationship between urinary incontinence (UI) severity and pelvic floor muscle activity in women with multiple sclerosis (MS). UI is common in MS and negatively affects quality of life, physical activity, and social participation. The study also explores how UI severity is associated with disability, fatigue, and overall quality of life.

Participants' demographic and clinical information, including age, disease duration, MS type, and disability level (measured by the Expanded Disability Status Scale, EDSS), will be recorded. Standardized questionnaires will assess urinary symptoms, their impact on daily life, physical activity, and fatigue. Pelvic floor muscle activity will be evaluated using surface electromyography (EMG) with biofeedback, conducted by trained physiotherapists.

The study will be conducted at the Pelvic Floor Health Center and is planned as a cross-sectional study. All assessments, including questionnaires and EMG measurements, are expected to take approximately 45 minutes per participant. Findings from this study aim to improve understanding of UI in women with MS and guide future interventions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of multiple sclerosis (MS) according to the 2017 revised McDonald criteria.

Female patients aged 30-50 years (age range with higher prevalence of urinary incontinence in MS).

Experiencing urinary incontinence (UI) symptoms according to the International Continence Society (ICS) definition.

EDSS (Expanded Disability Status Scale) score below 6.5.

Patients with no communication difficulties. -

Exclusion criteria

MS patients who do not provide consent to participate in the study.

MS patients who have had a medication change within the last 6 months.

Pregnant MS patients.

History of vaginal or cesarean delivery within the last 6 months.

Pelvic organ prolapse.

Urinary tract infection

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Treatment and study plan

Primary outcomes

  1. Pelvic floor muscle activity with surface EMG

    Time frame: baseline

    Evaluated using biofeedback-assisted surface EMG. Metrics recorded include mean EMG activity during contraction and rest phases, standard deviation of EMG activity, peak and minimum EMG values, contraction onset, and relaxation times

Secondary outcomes

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

    Time frame: baseline

    Assesses severity and impact of urinary incontinence

  2. Incontinence Impact Questionnaire (IIQ-7)

    Time frame: baseline

    Evaluates the effect of urinary incontinence on quality of life

  3. International Physical Activity Questionnaire (IPAQ)

    Time frame: baseline

    Assesses participants' physical activity levels

  4. Fatigue Severity Scale (FSS)

    Time frame: baseline

    Measures severity of fatigue experienced by participants

Study contacts

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

Büşra Aydın Erkılıç, MSc

CONTACT

[email protected]

905062214052

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

FACTORS ASSOCIATED WITH URINARY INCONTINENCE AND EVALUATION OF PELVIC FLOOR MUSCLE ACTIVITY IN PATIENTS WITH MULTIPLE SCLEROSIS: CROSS-SECTIONAL STUDY

Acronym: MS-UI-PFM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 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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