Do you experience pain with intercourse and/or suffer from

Vulvar Vestibulitis Syndrome (VVS)?

 

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)

 

3.                  You currently have a sexual partner and experience painful intercourse

 

4.                  You are premenopausal and NOT pregnant

 

 

Study Overview:

 

►    The research study involves the use of 5% lidocaine for the treatment of VVS

►    It will require 2 visits to UNC Hospitals over the course of 6 weeks

►    Participants will receive $50 for complete participation

 

 

If you are interested in participating,

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

 

What is the purpose of this research study?

Vulvar vestibulitis is a condition that affects the vulvar skin just outside of the vagina. It causes many women pain and often affects their ability to have sex. The diagnosis is usually based on your symptoms of pain and difficulty having sex. We also diagnose vestibulitis based on pain when we examine this area. There are many treatments used but we do not know which is the most effective. Currently, women with vestibulitis are treated with a variety of creams, pills, injections, physical therapy and even surgery. At our clinic we use higher dose estrogen and/or lidocaine cream, pills that help with nerve related pain, physical therapy and surgery to help treat our patients with vulvar vestibulitis. In a small study at our clinic, we have observed that symptoms in women with vestibulitis do improve with lidocaine. During that study, there were a few patients that had blood levels of lidocaine drawn in the morning (after applying it on at night). Their levels were very low.

We would like to look at the lidocaine ointment we have been using to see if it alone has any effect when compared to taking an inactive medication. This will help us determine if it alone helps symptoms or if there were other factors that lead to the improvement in our patients.

You MAY be able to participate in this research study if you:

• Are between the ages of 21-45
• Have been diagnosed by your doctor with VVS AND/OR
• Experience a burning sensation in the vaginal region upon contact (ex: intercourse, tampon insertion, pelvic exam)
• Currently have a sexual partner and experience painful intercourse
• You are premenopausal and NOT pregnant

You should NOT participate in the research study if you:

• Have gone through the change of life (menopause)
• Are diagnosed with nerve related pain from prior surgery or childbirth
• Are pregnant
• Had a baby within the past 2 months
• Are on any current medication for treatment of Vulvar Vestibulitis OR have used lidocaine in the past for vulvar vestibulitis

How many people will take part in this research study?

If you decide to be in this study, you will be one of approximately 56 people in this research study.

How long will your part in this research study last?

Your participation in this study will last for 8 weeks and will require 2 visits to the UNC Pelvic Pain Clinic over the course of 6 weeks.

Will you receive anything for being in this research study?

You will be receiving $50.00 if you complete the 8 weeks of the study and turn in the questionnaires. Parking vouchers will be provided.

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

This study is sponsored by UNC Center for Women's Health Research and 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