Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:25 PM
Study NCT ID:
NCT07489794
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle activity with surface EMG', 'timeFrame': 'baseline', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)', 'timeFrame': 'baseline', 'description': 'Assesses severity and impact of urinary incontinence'}, {'measure': 'Incontinence Impact Questionnaire (IIQ-7)', 'timeFrame': 'baseline', 'description': 'Evaluates the effect of urinary incontinence on quality of life'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'baseline', 'description': "Assesses participants' physical activity levels"}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'baseline', 'description': 'Measures severity of fatigue experienced by participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'urinary incontinence', 'Electromyography', 'Fatigue', 'Physical Activity'], 'conditions': ['Multiple Sclerosis', 'Urinary Incontinence (UI)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants' 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': 'Study limited to biological females due to pelvic floor muscle assessment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of multiple sclerosis (MS) according to the 2017 revised McDonald criteria.\n\nFemale patients aged 30-50 years (age range with higher prevalence of urinary incontinence in MS).\n\nExperiencing urinary incontinence (UI) symptoms according to the International Continence Society (ICS) definition.\n\nEDSS (Expanded Disability Status Scale) score below 6.5.\n\nPatients with no communication difficulties. -\n\nExclusion Criteria:\n\nMS patients who do not provide consent to participate in the study.\n\nMS patients who have had a medication change within the last 6 months.\n\nPregnant MS patients.\n\nHistory of vaginal or cesarean delivery within the last 6 months.\n\nPelvic organ prolapse.\n\nUrinary tract infection\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07489794', 'acronym': 'MS-UI-PFM', 'briefTitle': 'URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'FACTORS ASSOCIATED WITH URINARY INCONTINENCE AND EVALUATION OF PELVIC FLOOR MUSCLE ACTIVITY IN PATIENTS WITH MULTIPLE SCLEROSIS: CROSS-SECTIONAL STUDY', 'orgStudyIdInfo': {'id': 'MS-UI-PFM-2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational Group', 'description': 'Participants will be observed for EMG activity, fatigue, physical activity, and urinary incontinence symptoms.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Büşra Aydın Erkılıç, MSc', 'role': 'CONTACT', 'email': 'bsrr.aydinn@gmail.com', 'phone': '905062214052'}, {'name': 'Büşra Aydın Erkılıç, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istanbul, Prof. Dr. Cemil Taşçıoğlu City Hospital, Turkey', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Büşra Aydın Erkılıç, MSc', 'role': 'CONTACT', 'email': 'bsrr.aydinn@gmail.com', 'phone': '905062214052'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) from this study will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physiotherapist', 'investigatorFullName': 'Busra Aydin Erkilic', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}