Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
Study NCT ID:
NCT06224335
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2023-12-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence.', 'timeFrame': 'During the performance of sporting activities up to 60 minutes.', 'description': 'Intravaginal and intra-abdominal pressure will be measured in mmHg.'}], 'secondaryOutcomes': [{'measure': 'To detect the amount of urine leakage by an innovative pad test in sportwoman.', 'timeFrame': 'During the performance of sporting activities up to 60 minutes.', 'description': 'Leakage of urine will be measured by weight of pad in grams.'}, {'measure': 'To detect the degree of urinary leakage by the International Consultation on Incontinence Questionnaire in sportwoman.', 'timeFrame': 'During the performance of sporting activities up to 60 minutes.', 'description': 'Degree of leakage of urine will be measured by the International Consultation on Incontinence Questionnaire short form in score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress urinary incontinence', 'Athletes', 'Intravaginal pressure', 'Intra-abdominal pressure'], 'conditions': ['Stress Urinary Incontinence', 'Athletes']}, 'referencesModule': {'references': [{'pmid': '17497753', 'type': 'BACKGROUND', 'citation': 'Kruger JA, Dietz HP, Murphy BA. Pelvic floor function in elite nulliparous athletes. Ultrasound Obstet Gynecol. 2007 Jul;30(1):81-5. doi: 10.1002/uog.4027.'}, {'pmid': '39836175', 'type': 'DERIVED', 'citation': 'Hagovska M, Bukova A, Svihra J. Measurement of the Vaginal Pressure Profile with the Femfit(R) and Leakage Events Using a Newly Developed Pad Test during Selected Sports Activities: A Pilot Study. Int Urogynecol J. 2025 Apr;36(4):789-797. doi: 10.1007/s00192-025-06051-y. Epub 2025 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'To compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman.', 'detailedDescription': 'This is an observational comparative pilot study in which we will compare intravaginal and intra-abdominal pressure and an innovative pad test in 5 female athletes with stress urinary incontinence and 5 without incontinence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'sportwoman with high intensity of physical activity with and without stress urinary incontinence', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* nulliparous women\n* aged 18-35\n* high-intensity physical activity\n* performed sport at least three days per week, 90 minutes per day, for more than two years\n\nExclusion Criteria:\n\n* handicapped sportswomen\n* performance of various kinds of sport\n* no regular sport activity\n* performance of sports for less than two years\n* after childbirth\n* surgical treatment of gynaecological and urological illnesses\n* urinary tract infection\n* disease of respiratory tract\n* not sufficiently completed questionnaires\n* refusal to participate\n* body mass index greater than 30 (BMI = m/h2, where m = body weight in kilograms and h = body height in metres)\n* symptoms of overactive bladder'}, 'identificationModule': {'nctId': 'NCT06224335', 'acronym': 'SPORTVAGPRES', 'briefTitle': 'Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)', 'organization': {'class': 'OTHER', 'fullName': 'Comenius University'}, 'officialTitle': 'Femfit® and an Innovative Pad Test to Assess Pelvic Floor Muscle Activation During Physical Activity in Sportwoman with and Without SUI - a Pilot Study', 'orgStudyIdInfo': {'id': 'EC UNM 115/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sportwoman with high intensity of physical activity with stress urinary incontinence', 'description': 'High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years.', 'interventionNames': ['Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running']}, {'label': 'sportwoman with high intensity of physical activity without stress urinary incontinence', 'description': 'High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years.', 'interventionNames': ['Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running']}], 'interventions': [{'name': 'intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['intravaginal and intra-abdominal pressure with Femfit® device during (squeeeze, knack, rapid contractions, endurance contracions)', 'inovative pad test during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running'], 'description': 'Change in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities.', 'armGroupLabels': ['sportwoman with high intensity of physical activity with stress urinary incontinence', 'sportwoman with high intensity of physical activity without stress urinary incontinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03659', 'city': 'Martin', 'state': 'Slovakia', 'country': 'Slovakia', 'facility': 'Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}], 'overallOfficials': [{'name': 'Magdaléna Hagovská, Dr., PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'On request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comenius University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pavol Jozef Safarik University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}