Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT03940794
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2019-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment all participants will receive the same verbal instruction'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2019-05-05', 'studyFirstSubmitQcDate': '2019-05-05', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary bladder displacement in millimeters during verbal instructions', 'timeFrame': 'baseline', 'description': 'bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool'}], 'secondaryOutcomes': [{'measure': 'International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)', 'timeFrame': 'Baseline', 'description': 'Questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points.\n\nhigher values represent worse outcome'}, {'measure': 'Pelvic floor muscles endurance of contraction in seconds', 'timeFrame': 'Baseline', 'description': 'time of muscle contraction will be measured during the last contraction in each instruction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary incontinence', 'Pelvic floor muscle contraction', 'Transabdominal ultrasound', 'Verbal instructions'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '30152550', 'type': 'RESULT', 'citation': 'Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.'}, {'pmid': '15733051', 'type': 'RESULT', 'citation': 'Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.'}, {'pmid': '28977091', 'type': 'RESULT', 'citation': 'Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles (PFM) in patients with urinary incontinence.\n\nand to examine whether correct PFM contraction can be taught by transabdominal ultrasound, which is used as biofeedback.\n\nPelvic floor muscle contraction will be evaluated via transabdominal ultrasound.', 'detailedDescription': 'A self-controlled clinical trial is planned for patients who receive physiotherapy for pelvic floor rehabilitation at one of the Meuhedet Institutes\' physiotherapy clinics.\n\nEach participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you\'re trying to stop urinating". Those who will not be able to contract will be taught by the ultrasound as biofeedback.\n\nThe assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on-screen caliper and measurement tool will be used to measure bladder displacement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of urinary incontinence\n* Understand the language and simple instruction\n* Willing to participate in the study\n\nExclusion Criteria:\n\n* Has been treated before for pelvic floor rehabilitation by a physiotherapist\n* Received medication or surgery for the problem'}, 'identificationModule': {'nctId': 'NCT03940794', 'briefTitle': 'Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Ariel University'}, 'officialTitle': 'Pelvic Floor Muscle Contraction in Response to Different Verbal Instructions in Women With Urinary Incontinence - A Self-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'ArielU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verbal instruction', 'description': 'The participants will be instructed to contract the pelvic floor muscle with the following verbal instruction: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you\'re trying to stop urinating".Those who will not be able to contract will be taught by the ultrasound as biofeedback.', 'interventionNames': ['Other: Verbal instruction']}], 'interventions': [{'name': 'Verbal instruction', 'type': 'OTHER', 'otherNames': ['Trans abdominal Ultrasound examination for pelvic floor contraction'], 'description': 'Verbal instruction for pelvic floor contraction will be given to participants. A transabdominal Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.', 'armGroupLabels': ['Verbal instruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40700', 'city': 'Ariel', 'country': 'Israel', 'facility': 'Noa Ben Ami', 'geoPoint': {'lat': 32.1065, 'lon': 35.18449}}], 'overallOfficials': [{'name': 'Noa Ben Ami, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ariel University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ariel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}