Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-01 @ 5:35 PM
Study NCT ID:
NCT05707793
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ِAssessment of diaphragmatic force', 'timeFrame': '3 months', 'description': 'Diaphragmatic excursion will be measured, using an ultrasound device, by placing calipers at the bottom and top of the diaphragmatic inspiratory slope. All measurements will be taken at the end of expiration phase for women in both groups.'}, {'measure': 'Assessment of transverse abdominis thickness', 'timeFrame': '3 months', 'description': 'The measurement of transverse abdominis muscle will be taken from the lower border of internal obliques muscle to the inferior hyperechoic line of peritoneum at rest and during the abdominal drawing in maneuvers (ADIM) for women in both groups, using an ultrasound device.'}, {'measure': 'Assessment of lumbar multifidus thickness', 'timeFrame': '3 months', 'description': 'Lumbar multifidus will be measured, using an ultrasound device, along the line from the L4-5 zygapophyseal joint to the superior border of the lumbar multifidus for women in both groups.'}, {'measure': 'Assessment of pelvic floor muscle force', 'timeFrame': '3 months', 'description': "It will be assessed, using an ultrasound device, for women in both groups. The position of the bladder base at rest will be marked electronically with an 'X'. The subject will then perform a maximum voluntary pelvic floor muscle contraction and the image will be captured at the moment of maximum displacement. At this time, the subject will relax the pelvic floor muscles. The investigator will then measure the displacement to its current position in the stilled image and will be blinded to the measurement value until after the caliper has been fixed at the end point."}], 'secondaryOutcomes': [{'measure': 'Vaginal Laxity Questionnaire', 'timeFrame': '3 months', 'description': 'It is the only available tool for vaginal laxity assessment. Therefore, it will be used to exclude the diagnosis of vaginal laxity for women in group (A) and to confirm the diagnosis of vaginal laxity for women in group (B) through asking women to score vaginal laxity on a scale of 1 to 7, with 1 being very loose and 7 being very tight (Krychman et al., 2017).'}, {'measure': 'The Female Sexual Function Index (FSFI)', 'timeFrame': '3 months', 'description': 'The Female Sexual Function Index (FSFI) is a brief, multidimensional self-report instrument that will be used to assess the key dimensions of sexual function for women in both groups. The scale consists of 19 items yields domain scores in the following six areas: sexual desire, arousal, lubrication, orgasm, satisfaction and pain (Zachariou et al., 2017).'}, {'measure': 'Short-Form 36 Health Survey (SF-36)', 'timeFrame': '3 months', 'description': "It will be used to assess the quality of life for women in both groups. The scale is intended to assess disease burden and to assess the patient's quality of life as an indication of the patient's health status. It consists of 36 questions that evaluate eight domains: physical functioning (the ability to care for oneself and perform daily tasks); role limitations caused by physical health problems (the impact of one's physical health on one's capacity to perform daily tasks); bodily pain (the level of pain experienced whilst performing daily tasks); general health perceptions (how one sees one's own health); vitality (the capacity to carry out daily tasks); and social functioning. Scores range from zero (most affected) to one hundred (not affected) (Ramage et al., 2017)."}, {'measure': 'Modified Oxford grading scale', 'timeFrame': '3 months', 'description': 'The modified Oxford grading scale (with scores from 0 to 5) will be used to evaluate the pelvic floor muscle strength for women in both groups through measuring the vaginal digital palpation in a crock-lying position (Ferreira et al., 2011).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound imaging', 'core muscles activity', 'multiparous women', 'vaginal laxity'], 'conditions': ['Vaginal Laxity']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.', 'detailedDescription': 'Vaginal laxity is characterized by the loss of elasticity in the vaginal structure and vaginal looseness, which leads to symptoms including sexual dysfunction, dyspareunia, chronic pelvic pain, and urinary incontinence. It is a symptom of pelvic floor dysfunction. Its mechanisms are not well understood and it is usually worse in women with multiparity.\n\nSince the pelvic floor muscles (PFMs) are one of the core muscles that play a critical role in lumbopelvic stability, their impairment may affect the lumbopelvic area and the activity of other core muscles, like the transverse abdominis, lumbar multifidus, and diaphragm. Therefore, this study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'referred by gynecologists from the outpatient clinic for gynecology, Minia university Hospital, Minia, Egypt.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The participants' age range from 35 to 45 years\n2. their body mass index is 25-30 kg/m2,\n3. The number of normal deliveries ≤ three times,\n4. having a regular menstruation.\n5. They participate in the study after at least two years from their last delivery.\n\nExclusion Criteria:\n\n1. Prior history of disc prolapse and sacroiliac joints, symphysis pubic joint as well as lower limb problems, leg length discrepancy, and diastasis recti.\n2. Surgery related to the spine, abdomen or pelvis.\n3. Genital prolapse, urinary tract infection, and intrauterine device.\n4. Diabetes, chest and/or cardiac disease.\n5. Using any drugs for sexual dysfunction."}, 'identificationModule': {'nctId': 'NCT05707793', 'briefTitle': 'Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004230'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women suffering from vaginal laxity', 'description': 'self-reported perception of vaginal laxity on the Vaginal Laxity Questionnaire', 'interventionNames': ['Other: Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core muscles']}, {'label': 'normal subjects without vaginal laxity', 'description': 'No self-reported perception of vaginal laxity on the Vaginal Laxity Questionnaire', 'interventionNames': ['Other: Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core muscles']}], 'interventions': [{'name': 'Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core muscles', 'type': 'OTHER', 'description': 'Evaluation through Vaginal Laxity Questionnaire, Female Sexual Function Index, Short-Form 36 Health Survey, modified Oxford grading scale and ultrasound imaging', 'armGroupLabels': ['normal subjects without vaginal laxity', 'women suffering from vaginal laxity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'Minia university Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Doaa Osman, Assis. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deraya University', 'class': 'OTHER'}, {'name': 'Minia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Doaa A. Osman', 'investigatorAffiliation': 'Cairo University'}}}}