Effects of Contemporary Cycling Saddle Designs on Penile Transcutaneus Oxygen and Carbon Dioxide Levels in Elite Road Cyclists Riding on a Stationary Trainer (EC-SADDLE)

Milan Martínek

Status: Completed

Conditions: Healthy; Penile Numbness; Cyclists; Blood Gas Monitoring, Transcutaneous

Treatments: Device: Cycling on a home trainer; Device: Transcutaneous blood gas monitoring; Device: Biothesiometry; Device: Heart rate monitoring; Device: Bike Fitting; Device: Velomotrik smart cover BT

Study type: Interventional

Funder types: Other

Identifiers

NCT05887193

CharlesUCR - EC-SADDLE

UK FTVS 002/2023 (Other Identifier)

Details and patient eligibility

About

Aim of this research is to compare novel 3D printed cycling saddle with the bestselling saddles from two major cycling manufacturers in terms of effects on penile blood gasses and update these findings on current style of racing cycling saddles.

Full description

The aim of this research is to investigate whether Posedla's 3D printed and custom-made prototype bicycle saddle Joyseat (Posedla s.r.o., Varnsdorf, Czech Republic) 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 transcutaneus blood gas monitoring. 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 biothesiometer (Bio Medical Instruments Co., Newbury, Ohio, USA), which is again commonly used in studies of this type. The pressure of the riders contact surfaces on the saddle will be evaluated with Velometrik SmartCover BT pressure mat (Velometrik GmbH, Neukieritzsch, Germany). The Wahoo KICKR Bike (Wahoo Fitness, LLC., 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 (Specialized Bicycle Components, Inc., Morgan Hill, California, USA). The test will be performed using the described instrumentation in the Applied Kinesiology Laboratory at Charles University in Prague, Faculty of Physical Education and Sports and will involve riding 3x 10 minutes with 5 minutes rest in between intervals 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, i.e., the parameters of validity, reliability, sensitivity, specificity and availability.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• gender: male, age: 18-45 years, discipline: road cycling, annual mileage: more than 14000 km (Tier 3-4)

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 6 patient groups

Group 1

Active Comparator group

Description:

Order of saddle testing: Joyseat saddle - Specialized Power saddle - Fizik Tundra M5 saddle

Treatment:

Device: Velomotrik smart cover BT

Device: Bike Fitting

Device: Heart rate monitoring

Device: Biothesiometry

Device: Transcutaneous blood gas monitoring

Device: Cycling on a home trainer

Group 2

Active Comparator group

Description:

Order of saddle testing: Joyseat saddle - Fizik Tundra M5 saddle - Specialized Power saddle

Treatment:

Device: Velomotrik smart cover BT

Device: Bike Fitting

Device: Heart rate monitoring

Device: Biothesiometry

Device: Transcutaneous blood gas monitoring

Device: Cycling on a home trainer

Group 3

Active Comparator group

Description:

Order of saddle testing: Specialized Power saddle - Fizik Tundra M5 saddle - Joyseat saddle

Treatment:

Device: Velomotrik smart cover BT

Device: Bike Fitting

Device: Heart rate monitoring

Device: Biothesiometry

Device: Transcutaneous blood gas monitoring

Device: Cycling on a home trainer

Group 4

Active Comparator group

Description:

Order of saddle testing: Specialized Power saddle - Joyseat saddle - Fizik Tundra M5 saddle

Treatment:

Device: Velomotrik smart cover BT

Device: Bike Fitting

Device: Heart rate monitoring

Device: Biothesiometry

Device: Transcutaneous blood gas monitoring

Device: Cycling on a home trainer

Group 5

Active Comparator group

Description:

Order of saddle testing: Fizik Tundra M5 saddle - Joyseat saddle - Specialized Power saddle

Treatment:

Device: Velomotrik smart cover BT

Device: Bike Fitting

Device: Heart rate monitoring

Device: Biothesiometry

Device: Transcutaneous blood gas monitoring

Device: Cycling on a home trainer

Group 6

Active Comparator group

Description:

Order of saddle testing: Fizik Tundra M5 saddle - Specialized Power saddle - Joyseat saddle

Treatment:

Device: Velomotrik smart cover BT

Device: Bike Fitting

Device: Heart rate monitoring

Device: Biothesiometry

Device: Transcutaneous blood gas monitoring

Device: Cycling on a home trainer