URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS (MS-UI-PFM)

March 18, 2026 updated by: Busra Aydin Erkilic, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul, Prof. Dr. Cemil Taşçıoğlu City Hospital, Turkey
        • Contact:
        • Principal Investigator:
          • Büşra Aydın Erkılıç, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include female patients with multiple sclerosis (MS) aged 30-50 years, diagnosed according to the 2017 revised McDonald criteria, who experience urinary incontinence symptoms according to the International Continence Society (ICS) definition and have an EDSS score below 6.5. Participants must be able to communicate effectively. Patients who do not provide consent, have had a medication change within the last 6 months, are pregnant, have had a vaginal or cesarean delivery within the last 6 months, have pelvic organ prolapse, or have a urinary tract infection will be excluded.

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observational Group
Participants will be observed for EMG activity, fatigue, physical activity, and urinary incontinence symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time Frame: baseline
Assesses severity and impact of urinary incontinence
baseline
Incontinence Impact Questionnaire (IIQ-7)
Time Frame: baseline
Evaluates the effect of urinary incontinence on quality of life
baseline
International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline
Assesses participants' physical activity levels
baseline
Fatigue Severity Scale (FSS)
Time Frame: baseline
Measures severity of fatigue experienced by participants
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-UI-PFM-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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