Clincosm LogoSign in Get a demo

Comparison of Penile Oxygen Pressure.

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Completed
CT.gov ID
NCT05887193
Collaborator
(none)
30
Enrollment
1
Location
23
Actual Duration (Days)
39.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Biothesiometry
  • Device: Near Infrared Spectroscopy
  • Device: Cycling on a home trainer
  • Device: Bike Fitting

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.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Penile Oxygen Pressure: Comparison of Conventional and 3D Custom-made Saddle
Actual Study Start Date :
Apr 21, 2023
Actual Primary Completion Date :
May 14, 2023
Actual Study Completion Date :
May 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1

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

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

    • Device: Near Infrared Spectroscopy
    Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

    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 at 65-85% of each individual subjects maximal heart rate.

    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)
    Group 2

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

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

    • Device: Near Infrared Spectroscopy
    Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

    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 at 65-85% of each individual subjects maximal heart rate.

    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)
    Group 3

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

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

    • Device: Near Infrared Spectroscopy
    Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

    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 at 65-85% of each individual subjects maximal heart rate.

    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)
    Group 4

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

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

    • Device: Near Infrared Spectroscopy
    Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

    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 at 65-85% of each individual subjects maximal heart rate.

    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)
    Group 5

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

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

    • Device: Near Infrared Spectroscopy
    Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

    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 at 65-85% of each individual subjects maximal heart rate.

    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)
    Group 6

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

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

    • Device: Near Infrared Spectroscopy
    Penile oxygen pressure using TCM5 Flex and tc84 electrode (Radiometer Medical ApS, Brønshøj, Denmark) placed on glans penis.

    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 at 65-85% of each individual subjects maximal heart rate.

    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)

    Outcome Measures

    Primary Outcome Measures

    1. Difference in penile oxygen pressure on different types of saddles [Final comparison and data analysis of all anonymized values at the end of the research period within 4 months of end data collection]

      Statistical comparison of values recorded in mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charles University Prague Czechia 162 52

    Sponsors and Collaborators

    • Charles University, Czech Republic

    Investigators

    • Principal Investigator: Jitka Malá, PhDr. Ph.D., Charles University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles University, Czech Republic
    ClinicalTrials.gov Identifier:
    NCT05887193
    Other Study ID Numbers:
    • Snuparek, peritoneal area
    First Posted:
    Jun 2, 2023
    Last Update Posted:
    Jun 2, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Charles University, Czech Republic
    penile oxygen pressure
    cycling
    saddle
    pressure

    Study Results

    No Results Posted as of Jun 2, 2023