NCT07489794

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Mar 2026Oct 2026

Study Start

First participant enrolled

March 9, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

multiple sclerosisurinary incontinenceElectromyographyFatiguePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Pelvic floor muscle activity with surface EMG

    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 Outcomes (4)

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

    baseline

  • Incontinence Impact Questionnaire (IIQ-7)

    baseline

  • International Physical Activity Questionnaire (IPAQ)

    baseline

  • Fatigue Severity Scale (FSS)

    baseline

Study Arms (1)

Observational Group

Participants will be observed for EMG activity, fatigue, physical activity, and urinary incontinence symptoms.

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy limited to biological females due to pelvic floor muscle assessment
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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. -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul, Prof. Dr. Cemil Taşçıoğlu City Hospital, Turkey

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisUrinary IncontinenceFatigueMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Büşra Aydın Erkılıç, MSc

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations