Healthy Clinical Trial - Comparison of Penile Oxygen Pressure.

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT05887193
Study type	Observational
Source	Charles University, Czech Republic
Contact
Status	Completed
Phase
Start date	April 21, 2023
Completion date	May 14, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.