Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 5:47 AM
Study NCT ID:
NCT05193435
Status:
UNKNOWN
Last Update Posted:
2022-01-14
First Post:
2022-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-02', 'studyFirstSubmitDate': '2022-01-02', 'studyFirstSubmitQcDate': '2022-01-02', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary incontinence severity', 'timeFrame': 'change from baseline at 8 weeks', 'description': 'Urinary incontinence severity will be measured with A 1-hour pad test'}], 'secondaryOutcomes': [{'measure': 'Urinary symptoms', 'timeFrame': 'change from baseline at 8 weeks', 'description': 'Urinary symptoms will be evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form'}, {'measure': 'Life quality', 'timeFrame': 'change from baseline at 8 weeks', 'description': "Life quality will be assessed with King's Health Questionnaire."}, {'measure': 'Pelvic floor muscle activation response', 'timeFrame': 'change from baseline at 8 weeks', 'description': 'Pelvic floor muscle activation response will be measured with a portable EMG-Biofeedback device.'}, {'measure': 'Pelvic floor muscle strength', 'timeFrame': 'change from baseline at 8 weeks', 'description': 'Pelvic floor muscle strength will be evaluated with Modified Oxford Scale'}, {'measure': 'Core stability', 'timeFrame': 'change from baseline at 8 weeks', 'description': 'Core stability will be evaluated with Sahrmann Test using the pressure stabilizer.'}, {'measure': 'Balance', 'timeFrame': 'change from baseline at 8 weeks', 'description': 'Balance will be evaluated with Biodex Balance System as static and dynamic'}, {'measure': 'Spinal function', 'timeFrame': 'change from baseline at 8 weeks', 'description': 'Spinal function will be evaluated with the Spinal Mouse device in standing position.'}, {'measure': 'Subjective perception of improvement', 'timeFrame': 'After treatment (at 8 week)', 'description': 'Subjective perception of improvement will be measured with a four-point Likert scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '39704322', 'type': 'DERIVED', 'citation': 'Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence.', 'detailedDescription': 'Stress urinary incontinence is involuntary urinary incontinence with increased intraabdominal pressure. Different exercise approaches such as pelvic floor exercises and stabilization exercises are used in these patients. There is a need for studies comparing the effects of these exercises.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women between the ages of 18-65 who have symptoms of stress or stress-dominant mixed urinary incontinence, who volunteered to participate in the study\n\nExclusion Criteria:\n\n* Those who are pregnant, have communication and cooperation problems, have a concomitant neurological or rheumatological disease, have a history of surgery involving the abdominal and pelvic regions in the last year, have undergone spine surgery, those diagnosed with pure urge urinary incontinence or mixed type incontinence, those with advanced pelvic organ prolapse, those with a spinal deformity (such as scoliosis), the presence of orthopedic problems in the lower extremities (such as lower extremity shortness, presence of deformity etc.) and vestibular system disorder'}, 'identificationModule': {'nctId': 'NCT05193435', 'briefTitle': 'Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': '2022/01/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic floor exercise group', 'description': 'Pelvic floor exercises for muscle fiber types I and II will performed 3 days a week for 8 weeks', 'interventionNames': ['Other: Pelvic floor exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stabilization exercise group', 'description': 'Lumbar spinal stabilization exercises will performed 3 days a week for 8 weeks', 'interventionNames': ['Other: Stabilization exercises']}], 'interventions': [{'name': 'Pelvic floor exercises', 'type': 'OTHER', 'description': 'Pelvic floor exercises for types I and II muscle fibers will be performed', 'armGroupLabels': ['Pelvic floor exercise group']}, {'name': 'Stabilization exercises', 'type': 'OTHER', 'description': 'Lumbar spinal stabilization exercises will be performed', 'armGroupLabels': ['Stabilization exercise group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seyda Toprak Celenay', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90312 906 1000'}], 'overallOfficials': [{'name': 'Seyda Toprak Celenay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'seyda toprak celenay', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}