Clinical trial NCT05887193: Comparison of Penile Oxygen Pressure.
Official title: Comparison of Penile Oxygen Pressure: Comparison of Conventional and 3D Custom-made Saddle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: penile oxygen pressure
cycling
saddle
pressure
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 30
Sex: MALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* gender: male, age: 23-45years, discipline: road cycling, annual mileage: more than 7000km

Exclusion Criteria:

* 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Charles University
Study officials:
affiliation: Charles University
name: Jitka Malá, PhDr. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: