Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:52 AM
Study NCT ID:
NCT07322250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of stress urinary incontinence (SUI) symptoms.', 'timeFrame': 'baseline,10 weeks, 16 weeks', 'description': 'severity of SUI symptoms, measured by the Arabic version of the International consultation on incontinence questionnaire-short form (ICIQ-UI SF)'}], 'secondaryOutcomes': [{'measure': 'Quality of life (QOL)', 'timeFrame': 'baseline,10 weeks, 16 weeks', 'description': 'QOL will be measured by International consultation on incontinence questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS qol)'}, {'measure': 'self-esteem', 'timeFrame': 'baseline,10 weeks, 16 weeks', 'description': 'self-esteem will be measured by Arabic Rosenberg self-esteem scale'}, {'measure': "patient's global impression of improvement", 'timeFrame': 'baseline,10 weeks, 16 weeks', 'description': "patient's global impression of improvement will be measured by Patient Global Impression of Improvement (PGI-I) scale."}, {'measure': 'maximum voluntary isometric contraction (MVIC) of pelvic floor muscles', 'timeFrame': 'baseline,10 weeks, 16 weeks', 'description': 'maximum voluntary isometric contraction (MVIC) of pelvic floor muscles will be measured by Neurotrac myoplus pro EMG'}, {'measure': 'pelvic floor muscle resting tone', 'timeFrame': 'baseline,10 weeks, 16 weeks', 'description': 'pelvic floor muscle resting tone will be measured by Neurotrac myoplus pro EMG'}, {'measure': 'pelvic floor muscle endurance', 'timeFrame': 'baseline,10 weeks, 16 weeks', 'description': 'pelvic floor muscle endurance will be measured by Neurotrac myoplus pro EMG'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Menopausal Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'the purpose of the study is to investigate the effect of blood flow restriction training on postmenopausal SUI.', 'detailedDescription': "We have two groups: control group (A) and experimental group (B) are two matched post-menopausal stress urinary incontinence. Group A will receive PFMT-associated EMG biofeedback, whereas Group B will receive PFMT-associated EMG biofeedback while applying blood flow restriction to the proximal thigh. Our primary outcome measures will be the severity of SUI symptoms, while the secondary outcome measures will involve QOL, self-esteem, patient's global impression of improvement, maximum voluntary isometric contraction (MVIC) of pelvic floor muscles, pelvic floor muscle resting tone, and the endurance of pelvic floor muscles,"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. post-menopausal women, defined by the absence of vaginal bleeding for 12 months,\n2. body mass index (BMI) \\< 30\n3. They should have faced at least two leakage episodes each week and fall into the mild to moderate range of urinary incontinence, measured by (ICIQ-UI SF).\n4. Two standard questions about stress and urgency UI were used to determine the patient's eligibility.\n\nExclusion Criteria:\n\n1. pelvic organ prolapse greater than grade II on Baden-Walker classification system\n2. previous treatment for UI or hormone therapy, ongoing urinary tract infections, cognitive or neurological disorder, or inability to perform the proposed procedures.\n3. anyone with past or current injuries to the pelvis, hip joint, or spine, as well as those with uncontrolled diabetes, or those with prior experience in pelvic floor muscle training .\n4. the presence of uncontrolled hypertension.\n5. patients with a history of deep venous thrombosis (DVT), varicose Veins, cardiac disease, or lymphedema."}, 'identificationModule': {'nctId': 'NCT07322250', 'briefTitle': 'The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'KFSIRB200-800'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Control group will receive Pelvic floor muscle training-associated EMG biofeedback.', 'interventionNames': ['Other: pelvic floor muscle training -associated EMG-biofeedback.']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh.', 'interventionNames': ['Other: pelvic floor muscle training -associated EMG-biofeedback.', 'Other: blood flow restriction']}], 'interventions': [{'name': 'pelvic floor muscle training -associated EMG-biofeedback.', 'type': 'OTHER', 'description': 'The control group will receive pelvic floor muscle training-associated EMG biofeedback for 10 weeks', 'armGroupLabels': ['control group', 'experimental group']}, {'name': 'blood flow restriction', 'type': 'OTHER', 'description': 'experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh for 10 weeks.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jilan Adel, lecturer', 'role': 'CONTACT', 'email': 'gelan_youssif@pt.kfs.edu.eg', 'phone': '01007519909', 'phoneExt': '+2'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physical therapist', 'investigatorFullName': 'Hamdiah Mohmmed Altuwjry', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}