Do you suffer from Vulvar Vestibulitis Syndrome (VVS)

or experience pain with intercourse?

 OR

If you do not experience pain with intercourse, are you interested in

participating in our research as a healthy control subject?

 

You may be able to participate if:

1.                  You are between ages 21-45

 

2.                  You have been diagnosed by your doctor with VVS and/or experience pain in the vaginal region upon contact (e.g. intercourse, tampon insertion, pelvic exam)

OR    

You have no prior history of pain with intercourse or pain on contact.

 

3.                  You are premenopausal and NOT pregnant

                                                                

 

Study Overview:

 

►    The research study involves undergoing sensory testing and modified gynecological exams

►    It will require 2 visits to UNC Hospitals over the course of 2 weeks

►    Participants will receive $100 for complete participation

 

If you are interested in participating,

please call toll free at 1-866-857-9394.

 

 

What is the purpose of this study?

Vulvar vestibulitis syndrome (VVS), the most common type of chronic vulvovaginal pain, impairs the psychological, physical, and reproductive health of nearly 1 in 10 women at some point in their lifetime. The cause of VVS is not clearly understood and current treatments are only slightly effective.  The purpose of this research study is to learn how VVS develops so that in the future, better treatments can be found. 

The development of pain disorders, like VVS, is influenced by both genetic and environmental factors (e.g. stress, diet, medications, etc.). In order to understand how these influences interact, comprehensive research looking at genes in different groups of people is needed. Therefore, genetic material called DNA obtained from the white blood cells in your blood will be used to search for genes related to VVS. These results will be used to identify genetic differences between women who have VVS, do not have VVS, and those who suffer from varying degrees of symptoms.

A second goal of this study is to see whether women who have VVS and women who are healthy controls have symptoms of Irritable Bowel Syndrome (IBS) and whether there are genetic differences in their blood.  Some of the symptoms of IBS are diarrhea, abdominal pain and constipation.  IBS and VVS are both called idiopathic pain disorders.  This means that doctors do not know what causes them and they are thought to have similar nerve pathways that lead to pain and other symptoms.  Understanding how these conditions are the same may be important so better treatments and tests to diagnose the conditions can be developed. 

In the study, we plan to:

1.       Evaluate a modified algometer (pressure sensing instrument) designed to measure how sensitive your vulvar skin is to pain caused by pressure.  This tool is experimental and this is the first time we are using this tool for the purposes of research on human subjects.

2.       Evaluate a modified algometer (pressure sensing instrument) designed to measure how sensitive your pelvic floor muscles are to pain caused by pressure.  This tool is experimental and this is the first time we are using this tool for the purposes of research on human subjects.

3.       Compare women with VVS to women without VVS regarding sensitivity to pain in the vulvar area and in the pelvic muscles.

4.       Investigate the incidence of IBS among women with VVS compared to women without VVS.

5.       Compare genetic markers between healthy controls and women with varying degrees of VVS.

 

You are being asked to be in the study because you reported pain limited to intercourse or other types of contact (e.g. tampon use) for the past 3 months OR you have no prior history of painful intercourse or pain on contact.

 

Are there any reasons you should not be in this study?

You should not be in this study if:

1. You are under the age of 21 or over the age of 45

2.       You are menopausal (including surgical removal of BOTH ovaries)

3.       You are pregnant or breastfeeding

4.       You have daily pain in your pelvic region (pain in pelvic region, not associated with your period, that has lasted longer than 3 months)

5.       You have vulvo-vaginal pain not limited to intercourse or contact

6.       You have a history of vulvo-vaginal surgery excluding obstetrical lacerations (e.g. episiotomy)

7.       You have been told that you have vaginismus (a condition caused by involuntary muscle spasms around the vagina that cause it to close)

 

After the initial screening, you will undergo a screening gynecological examination. You may be ineligible for participation in this study if you are found to have the following conditions (after the gynecological examination):

1.  Vulvar dermatitis (inflammatory condition causing irritation of the skin on or around the  

vulva) identified on exam

2.  Vulvo-vaginal infection (e.g. yeast infection)

3.  Mild levels of tenderness in the vulvar region during the examination (for participants who are considered VVS-free and don’t report pain with intercourse and/or tampon use)

4.  Pelvic mass

5. Vaginismus

 

How many people will take part in this study?

If you decide to be in this study, you will be one of approximately 135 people in this research study.

 

How long will your part in this study last?

After the initial eligibility phone call and screening visit for eligibility, a variable amount a time takes place until the next visit.  Starting with Visit 1, your participation will last 2 weeks.  You

will visit the clinic two times during these two weeks.  Each visit should last between 1-2 hours.

 

What will happen if you take part in the study?

Study Visit 1: 

·         Consent for participation in this research study

·         Completion of questionnaires.  These questionnaires will ask you questions about demographics, medical history, vaginal pain symptoms and IBS symptoms

·         Recording of vital signs

¨        Screening gynecologic examination (Note: this exam is NOT a standard “well woman check up” and it shall NOT be considered a replacement for your annual visit with your doctor. We do not perform a ‘pap smear’ and other important screening tests that are done as part of the routine gynecological exam.) 

·         Test 1: Vulvar mucosal pain sensitivity by an examiner using the experimental pressure assessment device. We will use a cotton swab like the one used in the baseline examination session.  The tail end of the cotton swab will be attached to a device that will allow us to measure the applied force that causes first sensation of pain.

·         Test 2: Muscle pressure pain assessment.  The examiner will wear the experimental pressure sensing device, which is attached to a tiny thimble and placed under the examiner’s glove.  The sensor allows us to measure applied force.  While wearing this device, the examiner will apply pressure to the pelvic floor muscles.

·         Repeat Test 1 & 2.  A second examiner will repeat the skin and muscle sensitivity assessments.

·         Blood sample.  You will be asked to donate approximately 2 tablespoons of blood for genetic testing.  The blood sample will not be labeled with your name.  The sample will be labeled with a number and that number will only be linked to your name in a separate file kept locked.  The samples will be stored at UNC in Chapel Hill, NC, for analysis of genetic markers and pain-related biological chemicals.  The results of these studies will not be put in your health records.  Samples not completely used up in the testing will be destroyed at the end of the study.  There is no direct clinical benefit to donating the blood sample; you will not receive the results of the genetic tests.

Study Visit 2 (2 weeks later):

·         You will have a repeat assessment of mucosal and muscle sensitivity by two different examiners.  You will be examined by the same examiners in the exact same manners as Visit 1. 

 

What are the possible benefits from being in this study?

Research is designed to benefit society by gaining new knowledge.  You will not benefit personally from being in this research study. 

 

What are the possible risks or discomforts involved with being in this study?

This study does not involve treatment; therefore your participation represents low risk. Mild psychological discomfort and pain may be associated with the pain threshold and tolerance measurements. 

 

A gynecologic exam is a highly personal and sensitive experience. You may be psychologically distressed after consenting to a gynecologic exam after which you are found to be ineligible for a variety of reasons (see exclusion criteria). In order to minimize unanticipated psychological distress, we will provide you with examples of scenarios that are associated with disqualification following a gynecologic exam.  We will also inform you of our general plan for follow-up care.

 

We do not anticipate any adverse event in this study. However, in the course of a screening gynecologic examination, unsuspected conditions may be identified (e.g. tender uterosacral ligament or suspicious skin lesions). In such events, you will be given the following options: 1) to be evaluated the same day at the UNC consult clinic, 2) to follow up with your health care provider, or 3) to follow up with the Principal Investigator (Dr. Zolnoun) or one of her colleagues at the UNC pelvic pain clinic as a new patient; appointments will be made within 1-4 weeks of the screening pelvic exam. The clinical situation will dictate the urgency of the follow-up care. In the event you decide to follow up with you primary care provider, they will be provided with a typed document detailing any medical concerns and physical exam findings. Otherwise, all information collected by the study will be de-identified and not shared with any outside sources.

 

Given the highly personal nature of a gynecologic examination, you may experience mild psychological distress because you are undergoing multiple examinations by two different examiners. However, each testing session will only last an average of 3-5 min. Given such short duration of stimuli, we do not anticipate significant physical pain or psychological distress with the mucosal and pelvic muscle sensory assessment, even if you have VVS.  Furthermore, you may terminate and withdraw from the study at any point during the examination and testing process.

 

We do not anticipate any harm during the testing procedures. Though experimental, both devices are hand held sensors measuring applied force. They are like an electronic thermometer, except they measure strain (applied force) rather than temperature. Both devices have undergone standard electrical safety inspection by our biomedical engineering core.  Furthermore, unlike instruments used in electrocardiography, this device has no electrical contact with you. 

 

There is a low risk of infection or bruising associated with the blood sampling.  This usually doesn’t happen because sterile needles, alcohol scrub, and pressure applied to a subject’s arm after removal of the needle are used.  You might experience syncope (light-headedness or temporary loss of consciousness) associated with the needle stick. 

 

In addition, there may be uncommon or previously unknown risks that may occur.  You should report any problems to the researchers.  If you are planning to get pregnant, you should not be in the study.  If you become pregnant during the study, you should notify the researcher right away.

 

Will you receive anything for being in this study?

You will be receiving $100 for participating in this study ($30 for the first visit, $15 for the blood draw, and $55 for the second visit).

 

Will it cost you anything to be in this study?

It will not cost you anything in addition to what you will be billed for your routine medical care to be in this study.  All tests, visits or procedures other than what is done for this study will be related to medical care that is part of the usual care for your condition and would be suggested even if you decided not to be in the research study.

If you think you may be eligible, please call 1-866-857-9394

This study is sponsored by the Division of Advanced Laparoscopy and Pelvic Pain within the Department of Obstetrics and Gynecology at the UNC School of Medicine.

 

 

UNC Pelvic Pain Research Unit

4010 Old Clinic Building

UNC School of Medicine

Chapel Hill, NC 27599

Phone: 919-966-9189

Fax: 919-966-5833