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Sexual Health Research Clinic |
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University of Vermont |
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(802) 419 0820 |
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SHRC@uvm.edu |
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Can your sex life predict your risk for heart disease?
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Sexual Health Research Clinic |
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University of Vermont |
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(802) 419 0820 |
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SHRC@uvm.edu |
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This study is looking to see if there is a connection between sexual function and heart disease in women. Previous research has shown that, in some men, erectile dysfunction can be predictive of future heart disease, but there have not been any studies that have found the same relationship in women. Heart disease is the number one cause of death for women in the United States, and identifying women at risk before the first heart attack is particularly important.
This study looks at women’s sexual experiences and responses and their heart health to see if there is a connection. Generally healthy women who are between 25 and 45 years old, do not smoke, and are not on hormonal contraception may be eligible. Women who qualify for and complete both parts are eligible for compensation of up to $100 - $50 for the first session and $50 for the second.
If you think you may qualify and are interested in participating, please call the Sexual Health Research Clinic at (802) 419 0820 for a phone screening. If you do not qualify but think that some of your friends, neighbors or colleagues might, please pass this information on! |
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This study is open to women, between 25 and 45 years old, non-smokers, not on hormonal contraceptives and who are generally healthy. This study is divided into two parts. Results from Part 1 will indicate whether you qualify for Part 2. This study is being conducted by the University of Vermont.
We encourage you to call us and ask questions, and take the opportunity to discuss the study with anybody you think can help you decide whether you would like to participate or not. |
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We are investigating the association between blood flow in the vaginal walls during states of sexual arousal and healthiness of the blood vessels, particularly arteries. In men, we know that impairment in genital blood flow can be an indication of problems with blood vessels. Currently, there are no studies that have explored this relationship in women. Our final goal is to determine whether differences in sexual responses could be used to alert women to potential underlying problems with their blood vessels. This might help women make lifestyle changes to prevent future heart problems. While this study will not be able to answer all these questions, through the data you will provide, we will be able to start identifying whether there is evidence that the health of blood vessels and sexual responses are associated in women.
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This is a small pilot study where we will record data from approximately 120 women for Part 1 and 44 women for Part 2. Women who are on hormonal contraception (‘the pill’) are not eligible for this study. Neither are women who regularly take any medication, whether prescribed or over the counter.
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Part 1. The first visit will be held at the Sexual Health Research Clinic. A number of questionnaires and interview questions will be used to assess any sexual symptoms you may have noticed in the past year (approximately 40 minutes). We will also measure changes in blood flow in your vaginal walls during states of sexual arousal (approximately 10 minutes). To do this, we utilize a vaginal photoplethysmograph, a device that looks like a clear tampon. It contains a light source and a light detector. By emitting a small amount of light and measuring how much bounces back from your vaginal walls, the device measures changes to the inside of your vagina that are associated with increased blood flow. The research technician will describe how to insert and remove the device. You will be in a private room and will insert the device on your own. After the device is inserted, you will be sitting on a comfortable recliner chair and the research technician will operate a TV monitor from an adjacent room. You will watch a video about Russian culture (3 minutes) and a video showing you explicit sexual behaviors between heterosexual couples (5 minutes). During the videos, you will be asked to indicate your feelings of sexual arousal by operating a lever. The visit is estimated to last about one and a half hours.
Part 2. Based on the data we collected during Part 1, we will call you back within one week to inform you whether you qualify for Part 2. Part 2 consists of a visit at the General Clinical Research Center, located in Fletcher Allen, across the street from the Sexual Health Research Clinic. The visit is estimated to last 2 hours.
The following describes the tests that you will participate in at the General Clinical Research Center. |
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Sympathetic tone/Nervous system activity
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We will measure your blood pressure and heart rate using both a standard blood pressure cuff on your upper arm and a small cuff that is placed on your fingers and measures blood pressure and heart rate continuously through a different technique. A nurse will place electrodes on your chest to measure your heart rate and will ask you to blow in a device (Valsalva maneuver) to measure changes in your heart rate and blood pressure during this exercise. After baseline measurements are obtained you will be asked to perform a Valsalva maneuver by blowing into a mouthpiece for about 20 seconds. The mouthpiece has a small hole that allows air to escape and requires you to continue blowing to maintain a steady pressure. This is similar to what you might do if you wish to “clear your ears” while on an airplane flight. There will be no discomfort to this procedure, but it will require some effort as you blow into the tube. Your heart rate and blood pressure will be recorded during this maneuver. We will ask you to repeat the Valsalva maneuver a few times several minutes apart so that we can obtain reliable measurements of your efforts. Your blood pressure response to these efforts helps us understand how your nervous system works. (30 minutes).
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Heart blood flow studies
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In this study we will examine the blood flow coming from your heart. The blood flow is measured by an ultrasound machine. The blood flow from the heart is measured by an ultrasound probe that is placed on your chest and provides images of the blood moving through the heart. This involves placing an ultrasound probe over your heart in two places: one place in in the middle of your chest just to the left side of your breastbone and the second place is under your left breast. This test is done while you are lying on your back but leaning to your left side with a pillow under your right hip. This test takes approximately 5 minutes.
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Arm and leg blood flow studies
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We will also measure the ability of your blood vessels to open up in response to new blood flow. To do this we will use ultrasound and watch a blood vessel in your upper arm. We will then place a blood pressure cuff on that arm and inflate the cuff to a pressure higher than your normal blood pressure. This will temporarily reduce the flow of blood to the arm below the cuff. The cuff will remain inflated for a period of 5 minutes. Following release of the blood pressure cuff the ultrasound will be used for up to 5 minutes, watching and measuring the size and blood flow within the arm blood vessel. This same sequence will then be repeated for one of your legs. |
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Blood tests
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We will draw approximately 4 tablespoons of blood from your arm vein to use for analysis of chemicals that may be related to the health of your blood vessels. If you agree, we will also draw extra tubes of blood to have available for later analysis of chemicals or specific genetic or DNA components that we may not consider important now but which may become important as new information comes to light. You do not have to agree to have your blood stored for future analysis in order to participate in the study.
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We believe that the risks associated with this study are minor. |
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Part 1:
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You may find that some of the interview questions and questionnaires make you uncomfortable because they ask you personal questions about sexual symptoms. Also, some people may experience some embarrassment while they are exposed to the sexually explicit videos, although you will be alone in a private room and our technicians have received extensive training in this type of procedure. |
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Part 2:
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The risk of blood drawing includes the local discomfort from the needle, fainting, infection and the possibility of bruising or a blood collection known as a hematoma under the skin that can last for a few days.
During the test that measures blood flow in your arm and your leg, your arm or your leg may tingle strongly when the blood flow has been reduced and your arm or leg may ache. These symptoms go away once the blood pressure cuff has been released.
It is possible that you may experience a slight redness on your skin in the area where the electrodes were placed and you may feel a slight lightheadedness while you are asked to blow during the Valsalva maneuver.
None of these tests are intended to be diagnostic, and they do not replace any other medical tests recommended to you by a physician. If the results of these tests do suggest that you might have a medical problem, you will be advised to seek the help of your primary care physician. However, these tests may not find a medical problem that you have, including heart valve disease, and should not be used to diagnose or rule out any medical problems. |
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A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways: Health insurance companies and group health plans may not request your genetic information that we get from this research. Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums. Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
GINA does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA does not prohibit discrimination on the basis of an already manifest genetic disease or disorder. |
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There are no specific benefits to you for participating in this study other than knowing that you are contributing to a project that could help identify early signs of vascular disease in women.
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There are no expenses for you, other than the time that you will spend completing the study.
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All women completing Part 1 will receive $50 and women completing Part 2 will receive an additional $50.
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You may discontinue your participation in this study at any time. If you decide to terminate the study, your care outside this study and your relations with the faculty, staff, and administration at the University of Vermont or Fletcher Allen Hospital will not be changed in any way.
You should let Dr. Rellini or her research assistants know if you decide to stop taking part in the study.
You will be withdrawn from the study if you no longer meet the criteria for the study. For example, if you become pregnant or start taking medication, including hormonal birth control, you would no longer qualify for the study and could no longer take part. |
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A record of your progress will be kept in a confidential form at the Sexual Health Research Clinic. The security of your record will be maintained by Dr. Alessandra Rellini and Martin Seehuus, the research coordinator. The results of this study may eventually be published and information may be exchanged between medical investigators, but patient confidentiality will be maintained.
The Institutional Review Board and regulatory authorities will be granted direct access to your original medical and research records for verification of clinical trial procedures and/or data. If your record is used or disseminated for government purposes, it will be done under conditions that will protect your privacy to the fullest extent possible consistent with laws relating to public disclosure of information and the law-enforcement responsibilities of the agency. Please refer to the separate Authorization Form that explains more specifically how your personal health information will be used.
Your name, social security number, and address will be disclosed one time to either the University of Vermont’s Procurement Services Department or Fletcher Allen’s Account Payable Department for purposes of reimbursing you for participation in this study. Depending upon the amount you receive, this income may be taxable. Your information will be coded and this code and the information will be kept under lock and key with only authorized personnel accessing the data. |
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If you think you may qualify and are interested in participating, please call the Sexual Health Research Clinic at (802) 419 0820 for a phone screening. If you do not qualify but think that some of your friends, neighbors or colleagues might, please pass this information on!
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Can your sex life predict your risk for heart disease?
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Sexual Health Research Clinic |
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University of Vermont |
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(802) 419 0820 |
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SHRC@uvm.edu |