Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05887193
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2023-04-21
Brief Title:
Comparison of Penile Oxygen Pressure
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Comparison of Penile Oxygen Pressure Comparison of Conventional and 3D Custom-made Saddle
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The aim of this thesis is to investigate whether Joyseats 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 riders 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 cyclists power and heart rate using a chest strap The cyclists 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 cyclists 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 ie the parameters of validity reliability sensitivity specificity and availability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None