Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01337193
Status:
TERMINATED
Last Update Posted:
2014-11-14
First Post:
2011-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Exercise and Biofeedback on Symptoms of Incontinence 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'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Principal investigator has decided not to continue her PhD studies.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the ability to contract the pelvic floor muscles from baseline to the midpoint and completion of the study', 'timeFrame': 'baseline, 4 weeks, and 8 weeks', 'description': 'Pelvic floor muscle lift and length of pelvic floor muscle contraction will be measured using transabdominal ultrasound imaging. Ability to maintain continence during a cough will be measured by asking the participant to stand, contract the pelvic floor muscles, and cough. The participant will state whether or not they leaked urine.'}], 'secondaryOutcomes': [{'measure': 'Change in the number of incontinent episodes per week from baseline to the midpoint and conclusion of the study', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'Incidence of incontinent episodes will be measured using a 7-day bladder diary'}, {'measure': 'Change in quality of life from the baseline to the midpoint and completion of the study', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'Quality of life will be measured using the I-QOL questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stress urinary incontinence', 'exercise', 'pelvic floor muscles', 'biofeedback', 'rehabilitative ultrasound imaging'], 'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence.\n\nThe study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.\n\nAll participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.', 'detailedDescription': 'This study has been terminated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. women will need to be 20 years or older\n2. diagnosed with stress urinary incontinence (SUI).\n\nExclusion Criteria:\n\nwomen with:\n\n1. urge or mixed incontinence\n2. pelvic organ prolapse\n3. previous surgical treatment for incontinence\n4. current treatment for SUI (including medications)\n5. current pregnancy\n6. six months or less postpartum\n7. body mass index of ≥ 30\n8. recurrent vulvovaginitis\n9. current/recurrent urinary tract infections (UTI)\n10. non-English speaking.'}, 'identificationModule': {'nctId': 'NCT01337193', 'briefTitle': 'Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'Effect of Rehabilitative Ultrasound Imaging Biofeedback on Urinary Incontinence, Pelvic Floor Muscle Contractions and Quality of Life in Women With Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'SUI 16333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvic floor muscle exercises', 'description': 'Three pelvic floor muscle exercises will be performed with verbal cueing from the instructor.', 'interventionNames': ['Other: Pelvic floor muscle exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Pelvic floor exercises with biofeedback', 'description': 'Pelvic floor exercises will be performed with biobeedback cueing.', 'interventionNames': ['Other: Pelvic floor exercises with biofeedback']}], 'interventions': [{'name': 'Pelvic floor exercises with biofeedback', 'type': 'OTHER', 'description': 'Exercises will be performed with assistance of biofeedback cueing', 'armGroupLabels': ['Pelvic floor exercises with biofeedback']}, {'name': 'Pelvic floor muscle exercises', 'type': 'OTHER', 'description': 'Exercises will b performed with verbal cueing of investigator.', 'armGroupLabels': ['Pelvic floor muscle exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Woman's University", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Elaine Trudell-Jackson, PT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Texas Woman's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Advisor', 'investigatorFullName': 'Elaine Trudelle-Jackson', 'investigatorAffiliation': "Texas Woman's University"}}}}