Effect of Bike Seats on Male Perineal Blood FlowNCT01804725
Study of Bicycle Seat Effects on Male Perineal Blood Flow
An observational study of Effect of Bike Seats on Male Perineal Blood Flow, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The objective is to study the effects of bicycle riding and bicycle seats on blood flow to a man's reproductive organs. It has been shown that bicycle riding can affect a man's ability to have an erection. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Bike Seats on Male Perineal Blood Flow
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Volunteers will be recruited from the general population. Recruitment will be done using oral presentation, meetings, advertisement flyers.Participants will be avid cyclists and will not be at risk of undue influence( i.e UIC students).
Who may be able to join
- Healthy 18-64 male
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Phase 1: To Compare Perineal Artery Occlusion in Road and Stationary Models. Phase 2: To Test Different Seats for Perineal Arterial Occlusion.
The objective is to study the effects of bicycle riding and bicycle seats on blood flow to a man's reproductive organs. It has been shown that bicycle riding can affect a man's ability to have an erection. Each year, newer and better bicycle seats come out but these seats have not been adequately studied for their effects on blood flow in the genital region.
Read the detailed description
Introduction:
An independent market research company released a report in 1997, estimating the bicycling industry to be worth an astounding 4.5 billion dollars.(1) The magnitude of this number gives us an idea of the popularity of this sport. An important component of a bicycle is its saddle, which can affect comfort, performance, and the rider's health. Several studies have reported sexual side effects in male bicyclists, more specifically temporary genital numbness and erectile dysfunction. Goldstein et. al claimed in their article that prolonged pressure on the perineal region causes arterial damage resulting in erectile dysfunction in men. These results have triggered bike manufacturers to come up with various saddle designs that claim to reduce risks for men. For this project investigators want to correlate bike riding and its effects on the male reproductive organs by measuring the pressures exerted on the perineum and blood flow while cycling. Previous studies on this matter have shown that a higher percentage of bicyclists are effected by Erectile Dysfunction(ED) compared to the general population. There are many published studies on the hemodynamics of the penis using Pulse Oximetry, Doppler Ultrasound and CAPSV measurements. Investigators goal is to be able to measure the pressures exerted on the arteries supplying the penis via the saddle over the perineum. A study, which attempted to carry out a measurement similar to this, used pressure transducers placed on the saddle of a stationary bike. There are flaws in this study, which investigators want to improve upon in designing this research experiment. For example, placing the sensors on the saddle enables measurements of force on the saddle and does not directly relate to the pressures exerted on the perineum. In other words by placing the sensors on the saddle researchers will not be able to distinguish between the pressures exerted on the perineum and other body parts in contact with the sensors on the seat, such as the sit bones. Also, while using a stationary bike the physics of the body and forces on the perineum are very different compared to road bikes on the road and mountain bikes on rough terrain. Investigators study corrects these flaws.
Purpose of study:
Can investigators measure the blood flow to the perineum via the perineal arteries and see the effect of bicycle riding on the blood flow through these arteries?
Design:
This is a pilot study which involved 2 steps to determine perineal blood flow and how bicycle seats affect this flow. The first step will be to use doppler ultrasound to measure the perineal blood flow in the Ultrasound suite of the University Illinois Chicago Medical Center. At this visit, patients will be asked to lie down in a frog-leg/lithotomy position on an exam table to allow access to the perineum. The linear ultrasound probe (L12-55) will be used to measure the flow through the perineal/cavernosal arteries. By applying sequentially increasing pressure, the critical pressure for occlusion will be measured along with flow rates at various applied perineal pressures. The second step will involve a bicycle ride where perineal pressures will be measured. Investigators use disposable sensors and tegaderm to stick the sensors on the perineum. No shaving of the perineum will be required so long as the sensor is able to be secured. The recording device is credit card size and will attach to the bicycle. The subjects ride using six different bike seats in a standard road course and also on a stationary trainer. This will conclude the requirement of the patient. The pressures obtained on the bicycle ride will be compared to the critical occlusion pressures and flow-pressure relationships measured in the ultrasound suite.
Recruitment:
Patients will be recruited for the project via various bicycle meetings. Cyclist will be approached via oral presentation and they will be men between ages 18-64, avid cyclists and will not be at risk of undue influence (i.e. UIC students). Please see attached recruitment script.
Risks Involved:
The study involves minimal risk to the subject as the subject will already be a cyclist and will be used to the mild exercise involved of cycling. Sensors will not use any electric input and the patient is at no harm from them. All data will be acquired using noninvasive radiology, ultrasound with doppler.
- Keywords
- bike seats, Erectile dysfunction, Perineum, Impotence
- Medical subject headings
- Erectile Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Arteries occluding time for each seat
This measure indicates the time period the subjects are occluding their blood vessels in the perineal region. Different seats can occlude the arteries for different duration. So this measure tells us exactly what is the impact of each tested seat on male perineal blood flow.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startAug 2008
- Primary completion27 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Bike Seats on Male Perineal Blood FlowStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Craig Niederberger, University of Illinois Chicago
- Investigators
- Craig S Niederberger, M.D, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804725
- Sponsor's protocol ID
- 2007-0284
- Status last verified
- Oct 2017
- First submitted
- 1 Mar 2013
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1: To Compare Perineal Artery Occlusion in Road and Stationary Models. Phase 2: To Test Different Seats for Perineal Arterial Occlusion.
- ClinicalTrials.gov ID
- NCT01804725
- Acronym / sponsor ID
- 2007-0284
- Keywords
- bike seats, Erectile dysfunction, Perineum, Impotence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to study the effects of bicycle riding and bicycle seats on blood flow to a man's reproductive organs. It has been shown that bicycle riding can affect a man's ability to have an erection. Each year, newer and better bicycle seats come out but these seats have not been adequately studied for their effects on blood flow in the genital region.
Detailed description
Introduction:
An independent market research company released a report in 1997, estimating the bicycling industry to be worth an astounding 4.5 billion dollars.(1) The magnitude of this number gives us an idea of the popularity of this sport. An important component of a bicycle is its saddle, which can affect comfort, performance, and the rider's health. Several studies have reported sexual side effects in male bicyclists, more specifically temporary genital numbness and erectile dysfunction. Goldstein et. al claimed in their article that prolonged pressure on the perineal region causes arterial damage resulting in erectile dysfunction in men. These results have triggered bike manufacturers to come up with various saddle designs that claim to reduce risks for men. For this project investigators want to correlate bike riding and its effects on the male reproductive organs by measuring the pressures exerted on the perineum and blood flow while cycling. Previous studies on this matter have shown that a higher percentage of bicyclists are effected by Erectile Dysfunction(ED) compared to the general population. There are many published studies on the hemodynamics of the penis using Pulse Oximetry, Doppler Ultrasound and CAPSV measurements. Investigators goal is to be able to measure the pressures exerted on the arteries supplying the penis via the saddle over the perineum. A study, which attempted to carry out a measurement similar to this, used pressure transducers placed on the saddle of a stationary bike. There are flaws in this study, which investigators want to improve upon in designing this research experiment. For example, placing the sensors on the saddle enables measurements of force on the saddle and does not directly relate to the pressures exerted on the perineum. In other words by placing the sensors on the saddle researchers will not be able to distinguish between the pressures exerted on the perineum and other body parts in contact with the sensors on the seat, such as the sit bones. Also, while using a stationary bike the physics of the body and forces on the perineum are very different compared to road bikes on the road and mountain bikes on rough terrain. Investigators study corrects these flaws.
Purpose of study:
Can investigators measure the blood flow to the perineum via the perineal arteries and see the effect of bicycle riding on the blood flow through these arteries?
Design:
This is a pilot study which involved 2 steps to determine perineal blood flow and how bicycle seats affect this flow. The first step will be to use doppler ultrasound to measure the perineal blood flow in the Ultrasound suite of the University Illinois Chicago Medical Center. At this visit, patients will be asked to lie down in a frog-leg/lithotomy position on an exam table to allow access to the perineum. The linear ultrasound probe (L12-55) will be used to measure the flow through the perineal/cavernosal arteries. By applying sequentially increasing pressure, the critical pressure for occlusion will be measured along with flow rates at various applied perineal pressures. The second step will involve a bicycle ride where perineal pressures will be measured. Investigators use disposable sensors and tegaderm to stick the sensors on the perineum. No shaving of the perineum will be required so long as the sensor is able to be secured. The recording device is credit card size and will attach to the bicycle. The subjects ride using six different bike seats in a standard road course and also on a stationary trainer. This will conclude the requirement of the patient. The pressures obtained on the bicycle ride will be compared to the critical occlusion pressures and flow-pressure relationships measured in the ultrasound suite.
Recruitment:
Patients will be recruited for the project via various bicycle meetings. Cyclist will be approached via oral presentation and they will be men between ages 18-64, avid cyclists and will not be at risk of undue influence (i.e. UIC students). Please see attached recruitment script.
Risks Involved:
The study involves minimal risk to the subject as the subject will already be a cyclist and will be used to the mild exercise involved of cycling. Sensors will not use any electric input and the patient is at no harm from them. All data will be acquired using noninvasive radiology, ultrasound with doppler.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers will be recruited from the general population. Recruitment will be done using oral presentation, meetings, advertisement flyers.Participants will be avid cyclists and will not be at risk of undue influence( i.e UIC students).
Key inclusion criteria (1 listed)
- Healthy 18-64 male
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arteries occluding time for each seat
Time frame: two years
This measure indicates the time period the subjects are occluding their blood vessels in the perineal region. Different seats can occlude the arteries for different duration. So this measure tells us exactly what is the impact of each tested seat on male perineal blood flow.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig S Niederberger, M.D principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Bike Seats on Male Perineal Blood Flow, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arteries occluding time for each seat (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.