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

NCT ID: NCT05887193

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2023-05-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Cyclists Blood Gas Monitoring, Transcutaneous Penile Numbness

Keywords

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saddle pressure bicycling erectile dysfunction hypesthesia transcutaneous blood gas monitoring bike fit biothesiometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study employed a randomized, within-subject, crossover design with counterbalancing to evaluate the effects of three different cycling saddles on transcutaneous penile oxygen (TcPO₂) and carbon dioxide (TcPCO₂) pressures in elite male cyclists. Participants cycled for 10 minutes on each saddle on a stationary trainer, with 5 minute rest intervals between conditions. To minimize potential order effects, participants were randomly assigned to one of six saddle-order sequences.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

Biothesiometry

Intervention Type DEVICE

Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.

Transcutaneous blood gas monitoring

Intervention Type DEVICE

Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

Cycling on a home trainer

Intervention Type DEVICE

Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.

Bike Fitting

Intervention Type DEVICE

Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)

Heart rate monitoring

Intervention Type DEVICE

Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)

Velomotrik smart cover BT

Intervention Type DEVICE

Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Group 2

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

Group Type ACTIVE_COMPARATOR

Biothesiometry

Intervention Type DEVICE

Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.

Transcutaneous blood gas monitoring

Intervention Type DEVICE

Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

Cycling on a home trainer

Intervention Type DEVICE

Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.

Bike Fitting

Intervention Type DEVICE

Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)

Heart rate monitoring

Intervention Type DEVICE

Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)

Velomotrik smart cover BT

Intervention Type DEVICE

Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Group 3

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

Group Type ACTIVE_COMPARATOR

Biothesiometry

Intervention Type DEVICE

Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.

Transcutaneous blood gas monitoring

Intervention Type DEVICE

Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

Cycling on a home trainer

Intervention Type DEVICE

Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.

Bike Fitting

Intervention Type DEVICE

Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)

Heart rate monitoring

Intervention Type DEVICE

Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)

Velomotrik smart cover BT

Intervention Type DEVICE

Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Group 4

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

Group Type ACTIVE_COMPARATOR

Biothesiometry

Intervention Type DEVICE

Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.

Transcutaneous blood gas monitoring

Intervention Type DEVICE

Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

Cycling on a home trainer

Intervention Type DEVICE

Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.

Bike Fitting

Intervention Type DEVICE

Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)

Heart rate monitoring

Intervention Type DEVICE

Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)

Velomotrik smart cover BT

Intervention Type DEVICE

Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Group 5

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

Group Type ACTIVE_COMPARATOR

Biothesiometry

Intervention Type DEVICE

Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.

Transcutaneous blood gas monitoring

Intervention Type DEVICE

Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

Cycling on a home trainer

Intervention Type DEVICE

Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.

Bike Fitting

Intervention Type DEVICE

Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)

Heart rate monitoring

Intervention Type DEVICE

Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)

Velomotrik smart cover BT

Intervention Type DEVICE

Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Group 6

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

Group Type ACTIVE_COMPARATOR

Biothesiometry

Intervention Type DEVICE

Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.

Transcutaneous blood gas monitoring

Intervention Type DEVICE

Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

Cycling on a home trainer

Intervention Type DEVICE

Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.

Bike Fitting

Intervention Type DEVICE

Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)

Heart rate monitoring

Intervention Type DEVICE

Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)

Velomotrik smart cover BT

Intervention Type DEVICE

Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Interventions

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Biothesiometry

Biothesiometry using Biothesiometer (Bio Medical Instrument Co, Ohio, United States of America), placed on glans penis and second finger of nondominant hand.

Intervention Type DEVICE

Transcutaneous blood gas monitoring

Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

Intervention Type DEVICE

Cycling on a home trainer

Riding a static bike Wahoo Bike (Wahoo Fitness LLC, Atlanta, Georgia, United States of America) for 3x 10 minutes in Zone 3 (Andy Coggan methodology) calculated from each individual subjects self reported Functional Threshold Power.

Intervention Type DEVICE

Bike Fitting

Setting standardized posture of the rider on the bike using Retül technology (Retül, Specialized Bicycle Components Inc., Boulder, Colorado, United States of America)

Intervention Type DEVICE

Heart rate monitoring

Measuring heart rate using Wahoo TICKR chest strap (Wahoo Fitness LLC, Atlanta, Georgia, United States of America)

Intervention Type DEVICE

Velomotrik smart cover BT

Saddle pressure measurement, mean and max saddle pressure, saddle pressure distribution. (Velometrik GmbH, Neukieritzsch, Germany).

Intervention Type DEVICE

Other Intervention Names

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Neurothesiometer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Milan Martínek

OTHER

Sponsor Role lead

Responsible Party

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Milan Martínek

Mgr. Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Milan Martínek, Mgr., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Charles University, Czech Republic

Locations

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Charles University

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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UK FTVS 002/2023

Identifier Type: OTHER

Identifier Source: secondary_id

CharlesUCR - EC-SADDLE

Identifier Type: -

Identifier Source: org_study_id