Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT05887193
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2023-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Penile Oxygen Pressure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in penile oxygen pressure on different types of saddles', 'timeFrame': 'Final comparison and data analysis of all anonymized values at the end of the research period within 4 months of end data collection', 'description': 'Statistical comparison of values recorded in mmHg'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['penile oxygen pressure', 'cycling', 'saddle', 'pressure'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to compare novel 3D printed cycling saddle with the best selling saddle from two major cycling manufacturers in terms of effects on blood circulation in the peritoneal region.', 'detailedDescription': "The aim of this thesis is to investigate whether Joyseat's 3D printed and custom-made bicycle saddles provide a benefit in terms of increased penile blood flow compared to the best-selling saddles from two major bicycle manufacturers. The method chosen to measure blood flow, which is commonly used in studies of this type, is referred to as Near Infrared Spectroscopy. Measurement of tcpO2 and tcpCO2 in cyclists will be performed while riding on a cycling trainer using Radiometer TCM5 Flex (Radiometer Medical ApS, Brønshøj, Denmark) and a tc 84 electrode placed on the glans penis. Prior to the actual penile blood flow measurements, the sensitivity level of the n. pudendus (n. dorsalis penis) will be verified using biothesiometry (electronic tuning fork test, vibration), which is again commonly used in studies of this type. The pressure of the rider's contact surfaces on the saddle will be evaluated with pressure mat (Gebiomized GmbH, Münster, Germany). The Wahoo Bike (Wahoo Fitness, Limited Liability Company, Atlanta, Georgia, United States of America) will be used in the study, which, in addition to the possibility of individual seating adjustment, also allows to record the cyclist's power and heart rate using a chest strap. The cyclist's position on the bike will be measured and evaluated by infrared sensors and Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America). The test will be performed on the described instrumentation in the Applied Kinesiology Laboratory at Charles University in Prague, Faculty of Physical Education and Sports and will involve a maximum of 3x 20 min rides on the cycle trainer at 65-85% of the cyclist's maximum individual heart rate during one visit. All measurement methods and devices are non-invasive and painless. The choice of instruments was based on their use in previously published studies of similar type and on their quality, i.e., the parameters of validity, reliability, sensitivity, specificity and availability."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '23 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in the study will be deliberately approached and will in all cases be experienced or competitive cyclists with an annual mileage of over 7 000 km (maximum 28 000 km). Subjects will be recruited from a group of riders who already use a customised Joyseat saddle in their sporting career and the research group will be supplemented by professional cyclists from teams who have the option of having customised saddles made for their riders.', 'genderDescription': 'The study design accounts only for male genitalia for the placement of the tc84 electrode.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gender: male, age: 23-45years, discipline: road cycling, annual mileage: more than 7000km\n\nExclusion Criteria:\n\n* Participants other than male, diagnosed with erectile dysfunction, acute or chronic back pain, acute (especially infectious) illness or injury, and in recovery from illness or injury are not eligible for inclusion in the research'}, 'identificationModule': {'nctId': 'NCT05887193', 'briefTitle': 'Comparison of Penile Oxygen Pressure.', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Comparison of Penile Oxygen Pressure: Comparison of Conventional and 3D Custom-made Saddle', 'orgStudyIdInfo': {'id': 'Snuparek, peritoneal area'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle', 'interventionNames': ['Device: Biothesiometry', 'Device: Near Infrared Spectroscopy', 'Device: Cycling on a home trainer', 'Device: Bike Fitting']}, {'label': 'Group 2', 'description': 'Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle', 'interventionNames': ['Device: Biothesiometry', 'Device: Near Infrared Spectroscopy', 'Device: Cycling on a home trainer', 'Device: Bike Fitting']}, {'label': 'Group 3', 'description': 'Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle', 'interventionNames': ['Device: Biothesiometry', 'Device: Near Infrared Spectroscopy', 'Device: Cycling on a home trainer', 'Device: Bike Fitting']}, {'label': 'Group 4', 'description': 'Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle', 'interventionNames': ['Device: Biothesiometry', 'Device: Near Infrared Spectroscopy', 'Device: Cycling on a home trainer', 'Device: Bike Fitting']}, {'label': 'Group 5', 'description': 'Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle', 'interventionNames': ['Device: Biothesiometry', 'Device: Near Infrared Spectroscopy', 'Device: Cycling on a home trainer', 'Device: Bike Fitting']}, {'label': 'Group 6', 'description': 'Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle', 'interventionNames': ['Device: Biothesiometry', 'Device: Near Infrared Spectroscopy', 'Device: Cycling on a home trainer', 'Device: Bike Fitting']}], 'interventions': [{'name': 'Biothesiometry', 'type': 'DEVICE', 'otherNames': ['Neurothesiometer'], 'description': 'Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Near Infrared Spectroscopy', 'type': 'DEVICE', 'description': 'Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Cycling on a home trainer', 'type': 'DEVICE', 'description': 'Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes at 65-85% of each individual subjects maximal heart rate.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Bike Fitting', 'type': 'DEVICE', 'description': 'Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '162 52', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Jitka Malá, PhDr. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}