Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03238716
Status:
TERMINATED
Last Update Posted:
2019-08-21
First Post:
2017-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuromuscular Re-eduaction, Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Exercise for 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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Inability to recruit an adequate number of patients with stress urinary incontinence (based on inclusion / exclusion criteria) to participate in the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incontinence Impact Questionnaire - Short Form IIQ-7', 'timeFrame': 'baseline, 6 weeks, 3 months', 'description': '7 questions, each worth 0-3 points. The average score of items responded to is calculated, then multiplied by 33 1/3 to put the scores on a scale of 0 to 100. High scores indicate greater impact of incontinence.'}], 'secondaryOutcomes': [{'measure': 'Global Rating of Change Scale', 'timeFrame': '6 weeks, 3 months', 'description': '15 point self-report scale (-7 to 7). High rating indicates a greater impact of change'}, {'measure': 'Urinary pad per day usage', 'timeFrame': 'baseline, 6 weeks, 3 months', 'description': 'Number of urinary pads that the patient requires per day secondary to stress urinary incontinence'}, {'measure': 'Urogenital Distress Inventory', 'timeFrame': 'baseline, 6 weeks, 3 months', 'description': '6 questions, each worth 0-3 points. The raw score is divided by 6 then multiplied by 25 for the total score. High scores indicate more distress due to bladder symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare two different approaches for treating patients with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and electric dry needling versus neuromuscular re-education and impairment-based exercise. Physical therapists commonly use all of these techniques to treat stress urinary incontinence. This study is attempting to find out if one treatment strategy is more effective than the other.', 'detailedDescription': 'Patients with stress urinary incontinence will be randomized to receive 2 treatment sessions per week for up to 6 weeks (8-12 sessions total) of either: (1) neuromuscular re-education, impairment-based exercise and electric dry needling (2) neuromuscular re-education and impairment-based exercise'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 35 - 75 years\n2. Female\n3. Meet the diagnosis of stress urinary incontinence - urine leakage with increased abdominal pressure from laughing, sneezing, coughing, or other physical stressors on abdominal cavity and bladder\n\nExclusion Criteria:\n\n1. Urge urinary incontinence or mixed urinary incontinence\n2. Greater than second degree prolapse\n3. Previous surgical intervention related to female anatomy\n4. Urinary tract infection\n5. Unable to participate in movement such as walking, stair climbing, or resistance training\n6. Taking medication that impacts bladder function\n7. Serious cardiovascular, cerebral disease, psychiatric disorder, cognitively impaired, injury of cauda equine, and/or myelopathy\n8. Pregnancy\n9. Sacral nerve stimulator implanted\n10. Cardiac pacemaker, metal allergy, or severe needle phobia'}, 'identificationModule': {'nctId': 'NCT03238716', 'briefTitle': 'Neuromuscular Re-eduaction, Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Exercise for Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Alabama Physical Therapy & Acupuncture'}, 'officialTitle': 'Neuromuscular Re-education, Impairment-based Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Impairment-based Exercise for Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'AAMT0015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electric DN, NM Re-ed, Exercise', 'interventionNames': ['Other: Electric DN', 'Other: NM Re-ed', 'Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NM Re-ed and Exercise', 'interventionNames': ['Other: NM Re-ed', 'Other: Exercise']}], 'interventions': [{'name': 'Electric DN', 'type': 'OTHER', 'description': 'Dry needling with electric stimulation to the erector spine and paraspinal muscles in the lumbar / sacral region and tibialis anterior / posterior. Dry needling with electric stimulation of peri-neural tissue associated with lumbar / sacral nerve roots, pudendal nerve and posterior tibial nerve. 8-12 treatment sessions over 6 weeks.', 'armGroupLabels': ['Electric DN, NM Re-ed, Exercise']}, {'name': 'NM Re-ed', 'type': 'OTHER', 'description': 'sEMG targeting type I slow-twitch fibers and type II fast-twitch fibers. Type I fibers maintain continuous muscle activity over prolonged periods of time; therefore, training of type I fibers will be achieved through endurance and repetition training of the pelvic floor muscles. Type II fibers are recruited during sudden increases in intra-abdominal pressure, and these fibers will be recruited with "The Knack" training. The Knack is a term created to use rhythm or timing to the pelvic floor. Neuromuscular re-education will be performed during the first treatment, but it will be performed "as needed" on subsequent treatments.', 'armGroupLabels': ['Electric DN, NM Re-ed, Exercise', 'NM Re-ed and Exercise']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'Impairment-specific strength training, which may include transversus abdominis (TrA), gluteus maximus/medius/minimus and/or hip abductor/adductor muscle training. Treadmill, riding the recumbent bike at \\> 2 METs and/or stair climbing. Exercise training will be performed 7-11 treatment sessions over 6 weeks (following treatment 1).', 'armGroupLabels': ['Electric DN, NM Re-ed, Exercise', 'NM Re-ed and Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Physical Therapy Specialists', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'James Dunning, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Academy of Manipulative Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alabama Physical Therapy & Acupuncture', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy', 'investigatorFullName': 'James Dunning, DPT, MSc, FAAOMPT', 'investigatorAffiliation': 'Alabama Physical Therapy & Acupuncture'}}}}