Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 12:30 AM
Study NCT ID:
NCT07485556
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pelvic Floor Strengthening and Relaxation Exercises in Women Diagnosed With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants were divided into the following three groups: Group 1 strengthening exercise group, group 2 Relaxation Exercise Group: received pelvic floor muscle relaxation exercises. Group 3 Combined Exercise Group: received a combination of both strengthening and relaxation exercises targeting the PFM.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 Hours Voiding Diary', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks.', 'description': 'Patients were instructed to void into the container for 24 hours and record the volume of each urination. They were also asked to document all fluid intake, episodes of urgency, and any occurrences of UI.'}], 'secondaryOutcomes': [{'measure': 'Urogenital Distress Inventory (UDI-6)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'To evaluate lower urinary tract dysfunction and its impact on quality of life. The total score ranges from 0 to 18, and a higher score indicates a worse quality of life.'}, {'measure': 'Overactive Bladder Assessment Form (OAB-V8)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'To evaluate the severity of overactive bladder symptoms.The total score ranges from 0 to 40. The cutoff value for the total score has been calculated as 11. Scores above this value indicate that the individual has an overactive bladder.'}, {'measure': 'Patient Health Questionnaire (PHQ)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks.', 'description': 'To assess depressive symptoms. The total questionnaire score indicates depression severity as follows: scores of 1-4 correspond to minimal, 5-9 to mild, 10-14 to moderate, 15-19 to moderately severe, and 20-27 to severe depression.'}, {'measure': 'Incontinence Impact Questionnaire (IIQ-7)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks.', 'description': 'To assess the impact of urinary incontinence on quality of life. The total score ranges from 0 to 28, and a higher score indicates a worse quality of life.'}, {'measure': 'International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks.', 'description': 'To assess the impact of urinary incontinence on quality of life. The total score ranges from 0 to 21, and a lower score indicates a better quality of life. A score of 8 or higher is recorded as bothersome urinary incontinence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic floor', 'multiple sclerosis', 'relaxation', 'neurogenic bladder disorder'], 'conditions': ['Multiple Sclerosis', 'Neurogenic Bladder Disorder', 'Pelvic Floor Muscle Exercise']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the effects of pelvic floor strengthening and relaxation exercises on lower urinary tract dysfunction (LUTD), depression and quality of life (QoL) in women with Multiple Sclerosis (WwMS). The main questions it aims to answer are:\n\n* Are pelvic floor relaxation exercises effective on lower urinary tract dysfunction (LUTD)?\n* Is there a difference in the effect on LUTD symptoms between pelvic floor strengthening exercises and relaxation exercises? Participants were divided into three groups: pelvic floor strengthening, relaxation and combined (both pelvic floor strengthening and relaxation together) exercise groups. Participants were called every week for 8 weeks and an online session was held one day per week. Participants were asked to perform the exercises 3 times a day, every other day. Urogenital Distress Inventory (UDI-6), Incontinence Impact Questioonaire (IIQ-7), International Consultation on Incontinence Questionnaire-Short form (ICIQ-SF), Overactive Bladder Assessment Form (OAB-V8), 24-Hour Voiding Diary and Patient Health Questionnaire (PHQ) were used to evaluate.', 'detailedDescription': 'In MS, neurogenic bladder and lower urinary tract dysfunctions (LUTD) are common symptoms observed in approximately 75% of people with Multiple Sclerosis (PwMS) . Untreated urinary dysfunctions may lead to lower urinary tract infections, renal damage, emotional stress, sleep disturbances, social isolation, and a decline in quality of life (QoL) 6, 7. To manage neurogenic LUTD, the conservative treatment approaches constitute the first-line therapy for symptoms. Pelvic floor muscle exercises (PFME) have important role for treatment of urinary incontinence (UI) and neurogenic LUTD. Tension and spasm in the pelvic floor muscles (PFM) can lead to a variety of symptoms that negatively impact QoL, including voiding dysfunction, pain, sexual dysfunction, and anorectal disorders. Inadequate relaxation of the pelvic floor during micturition may result in symptoms such as urinary frequency, post-void residual urine, urgency, increased daytime voiding, and urge UI. Therefore, relaxation exercises targeting the PFM, as well as comprehensive pelvic floor rehabilitation, can be utilized in the management of these symptoms While PFM strengthening protocols have been utilized in the management of neurogenic LUTD in women with MS (WwMS), there is currently no therapeutic program in the literature that combines both relaxation and strengthening exercises applied simultaneously to the PFM. This study aims to evaluate the effects of a combined exercise protocol-targeting both relaxation and strengthening of the PFM-on neurogenic LUTD and depression in WwMS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants were eligible to participate if they:\n\n* were female and aged 18 years or older,\n* had a score of less than 6.5 on the Expanded Disability Status Scale (EDSS) and were ambulatory,\n* experienced neurogenic LUTD such as urgency, urge UI, urinary frequency, and nocturia,\n* had normal cognitive function, defined as a score above 24 on the Standardized Mini-Mental State Examination (SMMSE)-Turkish version.\n\nExclusion Criteria:\n\n* Participants were excluded if they:\n\n * had spasticity in the lower extremity muscles, particularly in the adductors,\n * experienced an MS relapse within the previous two months,\n * had a current urinary tract infection,\n * were pregnant,\n * had undergone urogynecological surgery within the past six months,\n * lacked access to or the ability to use tools required for telerehabilitation (e.g., internet, camera, microphone, or smartphone).'}, 'identificationModule': {'nctId': 'NCT07485556', 'briefTitle': 'Effects of Pelvic Floor Strengthening and Relaxation Exercises in Women Diagnosed With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Comparison of the Effects of Pelvic Floor Strengthening and Relaxation Exercises Delivered Via Telerehabilitation in Women Diagnosed With Multiple Sclerosis: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'E-77082166-302.08.01-240734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvic Floor Strengthening Group', 'description': 'Patients received PFM strengthening exercises and behavioral modification therapies.', 'interventionNames': ['Other: Pelvic Floor Strengthening Exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Pelvic Floor Relaxation Group', 'description': 'The patients in Group 2 were prescribed a total of eight relaxation exercises and behavioral modification therapy.', 'interventionNames': ['Other: Pelvic Floor Relaxation Exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Exercise Group', 'description': 'The patients in Group 3 were prescribed both pelvic floor relaxation and strengthening exercises and behavioral modification therapy.', 'interventionNames': ['Other: Combined Pelvic Floor Exercises']}], 'interventions': [{'name': 'Pelvic Floor Strengthening Exercises', 'type': 'OTHER', 'description': 'Patients received PFM strengthening exercises and behavioral modification therapies. Strengthening exercises consisted of maximal voluntary PFM contractions held for 5 seconds (fast-twitch training), and endurance exercises involved sustained contractions for 15 seconds (slow-twitch training). Ten repetitions were considered as one set. The number of sets was gradually increased-up to a maximum of four sets per session-based on muscle fatigue and adherence, as assessed during weekly online follow-ups. Patients were instructed to perform the exercises every other day. Weekly online sessions were conducted with each patient to monitor adherence, assess for any adverse effects, and adjust or progress the exercise program as needed. The intervention was carried out over a period of 8 weeks.', 'armGroupLabels': ['Pelvic Floor Strengthening Group']}, {'name': 'Pelvic Floor Relaxation Exercises', 'type': 'OTHER', 'description': "The patients were prescribed a total of eight relaxation exercises. These exercises included: Cat-Cow (spinal stretching) exercise, lumbar extensor muscles combined with PFM stretching (Balasana, Child's Pose), piriformis stretch, hip flexor stretch, PFM relaxation in a squat position (Malasana, Garland Pose), hip adductor stretch, Happy Baby Pose (Ananda Balasana), and supine pelvic floor relaxation (Supta Baddha Konasana, Reclining Butterfly Pose). The exercises were demonstrated to the patients during a video-based online session by a physiotherapist, who also instructed the patients to repeat the exercises to ensure proper technique. Patients were asked to perform each relaxation exercise for 20 seconds, repeating them 3 to 4 times. The number of repetitions and progression of the exercises were increased weekly based on the patient's tolerance.", 'armGroupLabels': ['Pelvic Floor Relaxation Group']}, {'name': 'Combined Pelvic Floor Exercises', 'type': 'OTHER', 'description': 'The patients were prescribed both pelvic floor relaxation and strengthening exercises. The pelvic floor exercises were given in the form of strengthening, endurance and relaxation exercises, similar to those in Group 1 and 2. Patients were instructed to perform the strengthening and relaxation exercises alternately, allowing rest intervals between exercises.', 'armGroupLabels': ['Combined Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06810', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'İlke Keser, Proffesor', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffesor', 'investigatorFullName': 'Ilke Keser', 'investigatorAffiliation': 'Gazi University'}}}}