Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:33 PM
Study NCT ID:
NCT07420569
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Pelvic Floor Rehabilitation in Chronic Stroke Survivors: Long-Term Efficacy, Optimal Protocols, and Adjunctive Therapies for Comprehensive Pelvic Floor Dysfunction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006699', 'term': 'Home Care Services'}], 'ancestors': [{'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009739', 'term': 'Nursing Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-01', 'size': 259943, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-04T15:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Oxford scale to determine pelvic floor muscle strength', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 6 months, 12 months.', 'description': 'Primary outcome measure'}], 'secondaryOutcomes': [{'measure': 'Female Sexual Function Index to assess sexual dysfunction in women', 'timeFrame': 'Baseline, 8 weeks, 16 weeks, 6 months, 12 months.', 'description': 'standardized tools to aid data collection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomised controlled trial'], 'conditions': ['Pelvic Floor Muscle Weakness', 'Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.6084/m9.figshare.30983716', 'label': 'Data set'}]}, 'descriptionModule': {'briefSummary': 'Evaluate long-term efficacy of multimodal PFMT in chronic stroke survivors with PFD.', 'detailedDescription': 'Stroke is a leading cause of disability, with pelvic floor dysfunction (PFD) affecting 25-79% of survivors, including urinary incontinence, fecal incontinence/constipation, and sexual dysfunction. Evidence gaps include long-term efficacy (\\>12 months), optimal PFMT protocols, adjunctive therapies (biofeedback, NMES), bowel/sexual domains, partner impacts, QoL correlations, and prognostic factors. This trial addresses these via a large-scale, multicenter RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45-85; first-ever stroke ≥12 months prior\n* Sexual dysfunction per FSFI/IIEF)\n* Able to follow two-stage commands.\n\nExclusion Criteria:\n\n* Pre-stroke PFD\n* Indwelling catheter\n* MoCA \\<18'}, 'identificationModule': {'nctId': 'NCT07420569', 'acronym': 'RCT', 'briefTitle': 'Multimodal Pelvic Floor Rehabilitation in Chronic Stroke Survivors: Long-Term Efficacy, Optimal Protocols, and Adjunctive Therapies for Comprehensive Pelvic Floor Dysfunction.', 'organization': {'class': 'OTHER', 'fullName': 'Iqra National University'}, 'officialTitle': 'Multimodal Pelvic Floor Rehabilitation in Chronic Stroke Survivors: Long-Term Efficacy, Optimal Protocols, and Adjunctive Therapies for Comprehensive Pelvic Floor Dysfunction - A Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'INU/REHAB/XC110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation.', 'description': 'Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation. Duration: 16 weeks supervised\n\n\\+ 36 weeks home maintenance (total 12 months follow-up). Setting: Eight rehabilitation centers in Pakistan (e.g., Swat Psychiatric Care \\& Rehabilitation Center, Al-Makki Rehabilitation Center, etc.).', 'interventionNames': ['Other: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Standard PFMT)', 'description': '3 supervised/week (weeks 1-8), 1/week (9-16) + home.', 'interventionNames': ['Other: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Intensified PFMT)', 'description': '5/week (1-8), 3/week (9-16) + home.', 'interventionNames': ['Other: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C (PFMT + Biofeedback)', 'description': 'Standard + vaginal/anal biofeedback (MAPLe®/Peritron™).', 'interventionNames': ['Other: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week', 'Other: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks.']}], 'interventions': [{'name': 'Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week', 'type': 'OTHER', 'description': 'Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation. Duration: 16 weeks supervised\n\n\\+ 36 weeks home maintenance (total 12 months follow-up). Setting: Eight rehabilitation centers in Pakistan (e.g., Swat Psychiatric Care \\& Rehabilitation Center, Al-Makki Rehabilitation Center, etc.).', 'armGroupLabels': ['Group A (Standard PFMT)', 'Group B (Intensified PFMT)', 'Group C (PFMT + Biofeedback)', 'Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation.']}, {'name': 'Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks.', 'type': 'OTHER', 'otherNames': ['Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home', 'Group B (Intensified PFMT): 5/week (1-8), 3/week (9-16) + home.', 'Group C (PFMT + Biofeedback): Standard + vaginal/anal biofeedback (MAPLe®/Peritron™)', 'Group D (PFMT + NMES): Standard + NMES (20 Hz, 300μs, 20 min, 3x/week). Weeks 17-52: Home maintenance with monthly coaching.'], 'description': 'Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation. Duration: 16 weeks supervised\n\n\\+ 36 weeks home maintenance (total 12 months follow-up). Setting: Eight rehabilitation centers in Pakistan (e.g., Swat Psychiatric Care \\& Rehabilitation Center, Al-Makki Rehabilitation Center, etc.).', 'armGroupLabels': ['Group C (PFMT + Biofeedback)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'country': 'Uganda', 'facility': 'IQRA University', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethical considerations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iqra National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Muslim khan', 'investigatorAffiliation': 'Iqra National University'}}}}