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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

  1. 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.

  1. First posted5 Mar 2013 (estimated)
  2. Study startAug 2008
  3. Primary completion27 Feb 2017
  4. Study completion28 Feb 2017

Resources

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)
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

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.

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