Phase 1: To Compare Perineal Artery Occlusion in Road and Stationary Models. Phase 2: To Test Different Seats for Perineal Arterial Occlusion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Arteries occluding time for each seat
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy 18-64 male
排除标准
- 未提供
结局指标
主要结局
Arteries occluding time for each seat
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Craig Niederberger
Clarence C. Saelhof Professor and Head
University of Illinois at Chicago
