Dr Sharon Viner, Clinical Research Physician at MAC Clinical Research, shares more about vulvodynia and how MAC will be trialling a potential new treatment for provoked vulvodynia.
What is Vulvodynia?
Let’s break it down:
The vulva is the name given to the outer part of the female genital area, which includes the labia, clitoris, and vestibule. It is not the same as the vagina, which is located inside the body, the vulva forms the entrance to the vagina. Dynia is another name for pain, so the term vulvodynia simply means vulvar pain.
In clinical practice, vulvodynia is a condition defined as vulvar pain without a clear identifiable cause that persists for over 3 months and is not caused by an infection, skin condition or other known medical cause.
An Underdiagnosed Condition
Vulvodynia is common and affects up to 16% of women of all ages1. However, it is largely underdiagnosed due to poor recognition of the condition and difficulties in making an accurate diagnosis. A study in 2003 indicated that 60% of women see three or more doctors before being diagnosed but some never receive a diagnosis at all2.
Women may not come forward to talk about their vulval pain because they feel embarrassed or stigmatised by not being able to partake in or enjoy sex. Those that do go on to seek medical advice frequently have tests that come back as “normal” leaving them feeling lost about their condition or even dismissed, but their pain is very real.
Breaking the silence around vulvodynia is vitally important in increasing awareness about the condition and will hopefully lead to an earlier diagnosis for many women.
Why does getting a diagnosis for vulvodynia take so long?
Vulvodynia is considered a diagnosis of exclusion, meaning other conditions must be ruled out first. The diagnosis is clinical. This means a doctor will listen to your description of the problem first and then examine your vulva, vagina and vaginal secretions to rule out infection, a skin problem or other condition such as vaginismus (involuntary tightening of the vaginal muscles). If any areas of the vulva appear abnormal the doctor may examine them with a magnifying instrument or take a biopsy (small sample of skin) of the area. The doctor is likely to perform a cotton-swab test. This is when gentle pressure is applied to parts of the vulva with a cotton bud and you are asked to rate the severity of the pain. This is to determine if there is tenderness in the vulvar region that is triggered by touch (provoked vulvodynia).
There are no specific investigations for vulvodynia – only tests to prove the pain is not caused by other conditions.
What does vulvodynia feel like?
Experiences vary widely but women often describe the pain as either burning, stinging, itching or stabbing in nature.
The pain may be generalised to the entire vulva and in some cases involving the skin around the inner thighs and buttocks (generalised vulvodynia) or be localised to the entrance of the vagina (vestibulodynia).
Vulvodynia may be further described as provoked (triggered by touch) or spontaneous (occurring without touch).
Some women have pain during sex or when using tampons whilst other women experience severe pain just from sitting and cannot sit for long periods. Some women cannot even wear underwear because of the pain.
Vulvodynia is often considered as “sexual pain”, but we also know that women experience vulval pain daily and it can be constant, not only associated with sex.
The condition can be debilitating, significantly impacting a woman’s quality of life, affecting their ability to carry out routine tasks, to work, socialise and develop intimate relationships.
What causes vulvodynia? What we know and what we don’t know…
It is considered an idiopathic pain disorder meaning there is no clear identifiable cause.
There is no commonly agreed cause for the condition because it isn’t defined by anything you can physically see. Women with vulvodynia usually have a regular-looking vulva. However, just because a doctor cannot see anything doesn’t mean you do not have the condition.
There are theories whether the pain is caused by a dysfunction in processing pain, or due to injury. For example, there may be an initial trigger such as a previous infection, inflammation, or injury to the vulva that in some way leads to nerve damage or an increase in sensitivity causing nerve pain3.
How is the condition managed?
We don’t know what causes vulvodynia; therefore, treatment is directed towards alleviating the symptoms. Doctors may treat the condition in different ways; some treatments may help some women but not others.
Treatments include local anaesthetic cream/gels applied directly to the vulva to help reduce vulval pain temporarily.
Topical hormonal creams such as oestrogen may improve the health of the vulval tissue, particularly when it is thin or dry due to a reduction in oestrogen during the menopause.
Oral pain medications that may be effective for other types of chronic pain are also used in vulvodynia e.g. tricyclic and SNRI antidepressants, or anti-convulsant medications, however these are often associated with undesirable side effects.
Psychosexual counselling may also be used in conjunction with medical treatments.
Rarely, as a last resort, women with provoked vestibulodynia may have surgery in the form of a vestibulectomy (removal of vestibule tissue) but not everyone would be appropriate for this type of surgery.
Can vulvodynia be cured?
No, there is no cure for the condition but there are a variety of treatments that can help control the symptoms.
Vulvodynia and research
Historically, there has been a lack of clinical research into vulvodynia. This is partly due to variations in diagnostic criteria, clinical uncertainty and difficulties in studying a sensitive population. Consequently, there is limited evidence to support diagnosis and treatment.
Can you explain the medication being researched and how it works?
The study medicine being researched is called Pudafensine. It is designed to increase dopamine, a natural chemical in the body that helps regulate pain.
Lower levels of dopamine are associated with patients reporting higher levels of pain. By replenishing dopamine levels, it is hoped that there will be a reduction in pain signalling.
Some studies have shown that Pudafensine can calm nerve pain and improve sexual function. It is thought this investigative medication could be developed as a treatment to help women living with vulvodynia.
Previous clinical studies have demonstrated that Pudafensine is safe and well tolerated (low side effects).
What will the vulvodynia research study involve?
The study medication, Pudafensine, is being investigated to evaluate the effect it has on the pain in the vestibule (part of the vulva) caused by insertion e.g. tampon or touch (provoked vestibulodynia). Any changes to pain during the study will be assessed using a tampon test, this will happen 6 times during the study.
The trial will last from between 56 and 80 days, the duration will be different for each participant to avoid times of menstruation. In all cases there will be no more than 7 outpatient visits. It is a placebo (an inactive medicine) controlled study, and you will receive the study medication or placebo at different time points, the order in which you receive them will not be known. This is determined purely by chance, a process known as randomisation.
During the trial, participants may be permitted to continue some medications for their vulval pain, but conditions will apply.
To register your interest in MAC’s clinical trial for Vulvodynia, visit our Vulvodynia Research Webpage.
References
1 International Journal of Women’s Health, 2014;6:437. Etiology, diagnosis, and clinical management of vulvodynia by Leslie A Sadownck
2 J Am Med Womens Assoc (1972) 2003 Spring;58(2):82-8. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia?
3 Ventolini G. Vulvar pain: anatomic and recent pathophysiologic considerations. Clin Anat. 2013;26:130–133. doi: 10.1002/ca.22160
