Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT04590157
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromodulation Effect of Laser Acupuncture on 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the control group received pelvic floor muscle training ,and the study group received the same program in addition to laser acupuncture on neurogenic acupoints'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle strength (PFMS)', 'timeFrame': '6 weeks', 'description': 'The pelvic floor muscle strength of all women in both groups was assessed pre- and post-rehabilitation program, using XFT-0010 Pelvic Muscle Trainer device'}, {'measure': 'Stress urinary incontinence (SUI) severity', 'timeFrame': '6 weeks', 'description': 'The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.'}, {'measure': 'International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).', 'timeFrame': '6 weeks', 'description': 'it is a validated subjective measure used to assess the Stress urinary incontinence and its impact on quality of life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromodulation', 'laser acupuncture', 'neurogenic acupoints', 'female stress urinary incontinence'], 'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'background:Stress urinary incontinence (SUI) is the most common type of urinary incontinence in women, as it involves involuntary leakage of urine , the current study was To determine the neuromodulation effect of Laser Therapy on Neurogenic Acupoints in female with stress urinary incontinence (SUI).', 'detailedDescription': 'Thirty women with SUI were randomly divided into two equal groups; the control group received pelvic floor muscle training , while the study group received the same pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints . The outcome measures were pelvic floor muscle strength (PFMS) , SUI severity assessed by Severity Index (SI) , and Incontinence Questionnaire-Short Form (ICIQ-SF). The outcome measures were assessed pre- and post-rehabilitation program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ranged from 30 to 45 years old\n* body mass index (BMI) was less than 30 kg/m2,\n* all women were non-smokers and they had a sedentary life style\n\nExclusion Criteria:\n\n* The participants were excluded if they had other types of urinary incontinence (urge or mixed)\n* urinary tract infection\n* pelvic organ prolapse\n* diabetes mellitus\n* respiratory diseases, chronic cough and constipation'}, 'identificationModule': {'nctId': 'NCT04590157', 'briefTitle': 'Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Neuromodulation Effect of Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T. REC/012/002930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints', 'interventionNames': ['Device: Low Level Laser Therapy', 'Other: Pelvic floor muscle training']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'received pelvic floor muscle training', 'interventionNames': ['Other: Pelvic floor muscle training']}], 'interventions': [{'name': 'Low Level Laser Therapy', 'type': 'DEVICE', 'description': 'Laser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points', 'armGroupLabels': ['study group']}, {'name': 'Pelvic floor muscle training', 'type': 'OTHER', 'description': 'exercise prodram as follow: from supine lying position with legs slightly apart the patient asked to contract the pelvic muscles as hard as possible and hold for 10 seconds', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'El-Sheikh Zayed City Giza 1133 Egypt', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'faculty of physical therapy October 6 University', 'role': 'CONTACT', 'email': 'pt@o6u.edu.eg', 'phone': '0238362496'}], 'facility': 'October 6 University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Lama S Mahmoud, PHD', 'role': 'CONTACT', 'email': 'lamaelsedawyy@hormail.com', 'phone': '01157592636'}, {'name': 'Doaa A Osman, PHD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Doaa A Osman, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "lecturer, department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,Egypt"}, {'name': 'Khadiga S Abdulaziz', 'role': 'STUDY_DIRECTOR', 'affiliation': "professor,department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,egypt"}, {'name': 'Doha R Ahmed, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physiotherapy, Ahmed Maher Teaching Hospital, Cairo, Egypt'}, {'name': 'Emad E Atiya, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Department of Urology, Ahmed Maher Teaching Hospital, Cairo, Egypt'}, {'name': 'Lama S Mahmoud, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer, Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lama Saad El-Din Mahmoud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity', 'investigatorFullName': 'Lama Saad El-Din Mahmoud', 'investigatorAffiliation': 'October 6 University'}}}}