Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT03507660
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2018-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Verbal Instruction for Contraction Pelvic Floor Muscles Among Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'all participants will receive the same six verbal instruction given in a random order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2018-04-15', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary bladder displacement in millimeters during verbal instructions', 'timeFrame': 'up to 6 months', 'description': 'bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool'}], 'secondaryOutcomes': [{'measure': 'demographic self reported questionnaire regarding height', 'timeFrame': 'baseline', 'description': 'height in meters'}, {'measure': 'demographic self reported questionnaire regarding weight', 'timeFrame': 'baseline', 'description': 'weight in kilograms'}, {'measure': 'self reported questionnaire regarding physical activity', 'timeFrame': 'baseline', 'description': 'number of practice per week'}, {'measure': 'BMI', 'timeFrame': 'baseline', 'description': 'measured in kg/m\\^2 and calculated from the reported values of weight and height'}, {'measure': 'pelvic floor muscles endurance of contraction in seconds', 'timeFrame': 'up to 6 months', 'description': 'time of muscle contraction will be measured during the last contraction in each instruction'}, {'measure': 'questionnaire regarding symptoms of urinary incontinence = International Consultation on Incontinence Questionnaire - Short Form', 'timeFrame': 'baseline', 'description': 'scale range 0-21 points. higher values represent worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['verbal instruction, pelvic diaphragm, muscle contraction'], 'conditions': ['Pelvic Floor Muscle Weakness']}, 'referencesModule': {'references': [{'pmid': '26642347', 'type': 'RESULT', 'citation': 'Stafford RE, Coughlin G, Lutton NJ, Hodges PW. Validity of Estimation of Pelvic Floor Muscle Activity from Transperineal Ultrasound Imaging in Men. PLoS One. 2015 Dec 7;10(12):e0144342. doi: 10.1371/journal.pone.0144342. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effectiveness of different verbal instruction on pelvic floor muscle contraction among males. Pelvic floor contraction will be measured via ultrasound.', 'detailedDescription': 'This study will examine pelvic floor muscle contraction following six different verbal instructions among males. Physical-therapy students will be recruited to complete a survey and non-invasive transabdominal ultrasound assessment.\n\nA bladder filling protocol will be implemented to ensure subjects will have sufficient fluid in their bladders to allow clear ultrasound imaging. This protocol involved subjects consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a crook-lying supine position with a pillow under their heads for comfort.\n\nAll participants will be given six different verbal instructions to contract pelvic floor muscles. Each contraction will be performed 3 time with rests of 10 sec between contractions. While the first 2 contractions for each verbal instruction will be held for 3 sec. the last contraction will be held as long as the participant can conduct and the time of contraction will be measured as well. The pelvic floor contraction will be measured by assessing bladder displacement via diagnostic ultrasound.\n\nTo image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) 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': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'this research will include male population only', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willing to participate in the study\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03507660', 'briefTitle': 'Verbal Instruction for Contraction Pelvic Floor Muscles Among Males', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'What is the Best Verbal Instruction for Contraction the Pelvic Floor Muscles Among Males', 'orgStudyIdInfo': {'id': 'AU-NBA-20180315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'verbal instruction', 'description': 'The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:\n\n1. "squeeze the pelvic floor muscles".\n2. "squeeze and lift the pelvic floor muscles as if stopping the flow of urine"\n3. "Take a moderate breath in, let the breath out, draw in and lift your pelvic floor."\n4. ""squeeze the anus"\n5. "shorten the penis"\n6. "elevate the scrotum"', 'interventionNames': ['Other: verbal instruction']}], 'interventions': [{'name': 'verbal instruction', 'type': 'OTHER', 'otherNames': ['diagnostic ultrasound assesment'], 'description': 'Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.', 'armGroupLabels': ['verbal instruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ariel', 'country': 'Israel', 'facility': 'Ariel University, Department of Physical Therapy', 'geoPoint': {'lat': 32.1065, 'lon': 35.18449}}], 'overallOfficials': [{'name': 'Gali Dar, PHd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Haifa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'The result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.', 'ipdSharing': 'YES', 'description': 'The result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.', 'accessCriteria': 'according to journal policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ariel University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior lecturer', 'investigatorFullName': 'Gali Dar', 'investigatorAffiliation': 'University of Haifa'}}}}