Other Research Studies

To view summaries of studies that are currently enrolling participants, please click on the states/country names listed below. Additional studies can be viewed at: http://www.clinicaltrials.gov/ct/search?term=vulvar+vestibulitis and http://www.clinicaltrials.gov/ct/search?term=vulvodynia

Online Studies

University of Tasmania, Deakin University, University of Adelaide, Western Sydney University, McMaster University (Canada), and the NECST Network.
Subject

A Longitudinal Study of Health-Related Quality of Life, Body Image and Sexual Function in People Living with Gynaecological Disorders.

Contact

To participate in this study, please fill out the form found at the following link https://redcap.utas.edu.au/surveys/?s=L9J8HP97PN. If you have any questions or concerns, please contact Dr. Leesa Van Niekerk by email Leesa.Vanniekerk@utas.edu.au or phone +61 3 6226 6645.

Requirements

Requirements: If you are 18+ years old, assigned female at birth, and you have vulvodynia they are especially interested in hearing from you. If you are someone who experiences symptoms associated with diagnoses such as endometriosis, adenomyosis, persistent pelvic pain (e.g., vaginismus, interstitial cystitis), and polycystic ovary syndrome, you may also be eligible to participate in this study. Anyone interested in participating will be asked to fill out an expression of interest form (found at the below link) and will receive a link to your unique survey 24 to 48 hours from the time of your initial expression of interest. This survey link will allow you to complete a “Baseline” survey that asks you general information about yourself such as age, gender, and country of birth, and questions about your general physical and emotional health. You will also be asked questions about how you view your body and sexual intimacy. A description of the different survey sections will be available at the start of the section and the survey has been designed so that you can save your responses and come back to complete them at any time prior to submitting your responses. Once you have completed the “Baseline” survey, they will e-mail you a link to follow-up surveys 3 months, 6 months, 12 months, and 18 months later. This will allow them to learn more about how health-related quality of life, body image, and sexual satisfaction vary over time. For more information, please go to the website link included below.

Website

https://redcap.utas.edu.au/surveys/?s=L9J8HP97PN

University of Illinois Chicago, College of Nursing
Subject

Vulvar Pain and Ehlers-Danlos Syndrome (EDS) or Hypermobility Spectrum Disorder (HSD)

Contact

For contact information, please go to the website:

https://uic.ca1.qualtrics.com/jfe/form/SV_0BMhccD1Pp0hYTY?fbclid=IwAR32i-dTLmRQKAJXst5mstg4sku8cHthvB-Ev3iO9vKbpwkm7gJJt00dK6Q

Requirements

If you are a person assigned female at birth/people with vaginas who may have vulvodynia (genital pain), or you have been diagnosed with an Ehlers-Danlos syndrome (EDS) or Hypermobility Spectrum Disorder (HSD), you may be elegible to participate in this study. Questions will be about general pain (pain that occurs anywhere in the body outside of the genitals) AND/OR vulvar pain (pain in external genitals). You do not need to have both types of pain to participate.
 
Participation will take 1 to 2 hours and you have 72 hours to complete the survey, with the ability to leave the survey and return later to complete it.
 
For more more information, please go to the website included below:

Website

https://uic.ca1.qualtrics.com/jfe/form/SV_0BMhccD1Pp0hYTY?fbclid=IwAR32i-dTLmRQKAJXst5mstg4sku8cHthvB-Ev3iO9vKbpwkm7gJJt00dK6Q

The Swedish Agency for Health Technology Assessment and Assessment of Social Service (SBU)
Subject

Development of a Core Outcome Set for Treatment Studies of Provoked Vestibulodynia

Contact

For contact information, please go to the website https://www.sbu.se/pvd_en

Requirements

All participants will receive two surveys, and you will be asked to rank how important you think the different outcomes are. The prioritization of outcomes will be done by a panel consisting of persons who have experience (such as lived experience, research experience or clinical experience) with provoked vestibulodynia.
 
Before answering the surveys, participants will need to provide contact information, country of residence, and your perspective in the project. You will be asked to choose from one of the following perspectives:
 
-Persons with ongoing or past experience of provoked vestibulodynia
-Relatives of those with ongoing or past experience of provoked vestibulodynia
-Healthcare staff
o Medical doctors (gynaecologist/ dermatologist/ general practitioner)
o Physiotherapists
o Psychologists/other mental healthcare providers (sex therapists etc)
o Midwives
o Other relevant occupations
-Researchers
-Others (patient associations, research funders, systematic reviewers, HTA-personnel, decision-makers and industry).
 
For more details, please go to the website included below.

Website

https://www.sbu.se/pvd_en

United States

California

University of California Los Angeles (Los Angeles, CA)
Subject

Participants Needed for a Study on Vestibulodynia (Pain at the opening of the vagina with touch, sexual contact and/or tampon use).

Contact

For more information please contact Eva Gonzales at:
obgynresearch@mednet.ucla.edu
(310) 206-6049

Requirements

If you are a female 18-50 years of age who has had at least 3 continuous months of pain at the vaginal opening with touch, tampon use, and/or sexual contact, you may be eligible to participate in this study. This study is open for enrollment at UCLA Westwood Medical Plaza and will remain open for 4 more years. Study involvement includes 4 study visits over a six month time period. Participants are given free medication, free parking and compensation for their time.

Website

https://sites.duke.edu/updatestudy/

New York

UBMD Obstetrics and Gynecology (Buffalo, NY)
Subject

Vulvodynia Pain Thresholds

Contact

For more information, please contact Vanessa Barnabei, MD,Phd by phone 716-881-7564 or email vmbarnab@buffalo.edu

Requirements

Ages Eligible for Study: 18 Years to 50 Years (Adult)
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Vulvodynia is a sex-specific disorder. Only women will be enrolled.
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample


Study Population
Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other vulvar disorders.


Inclusion Criteria:
women meeting criteria for vulvodynia women seeking care for routine gynecologic exam


Exclusion Criteria:
women less than 18 years of age current pregnancy women with vulvar or vaginal disorder other than pain

Website

https://clinicaltrials.gov/ct2/show/study/NCT04461210?cond=vulvodynia&draw=2&rank=3

North Carolina

University of North Carolina School of Medicine (Chapel Hill, NC)
Subject

A Necessary Multi-Parametric Evaluation of Vulvodynia

Contact

If you are interested in taking part in this study, please go to the following page http://www.med.unc.edu/ppru/research and click on the “Registry” link at the bottom of the page.

Requirements

Women between the ages of 21 and 75 who have been diagnosed by their doctor with vulvodynia and/or experience pain in the vaginal region upon contact (ie. tampon use, intercourse, or pelvic exam) or without contact, for at least 3 months, may be eligible to participate in this study.

The research study involves undergoing sensory testing, a modified gynecological exam and will require 3 visits to the University of North Carolina. Participants will receive up to $200 for complete participation. The purpose of this study is to get a better understanding of a chronic pain syndrome called vulvodynia, or pain in the vulvar (pelvic) region.

Website

http://www.med.unc.edu/ppru/research/current-research-1/a-necessary-multi-parametric-evaluation-of-vulvodynia

University of North Carolina (Chapel Hill, NC)
Subject

Participants Needed for a Study on Vestibulodynia (Pain at the opening of the vagina with touch, sexual contact and/or tampon use).

Contact

To find out if you are eligible or if you want more information, please contact Debbie Farb at:
debbie.farb@unc.edu
(919) 886 – 3024

Requirements

If you are a female 18-50 years of age who has had at least 3 continuous months of pain at the vaginal opening with touch, tampon use, and/or sexual contact, you may be eligible to participate in this study. This study is open for enrollment at UNC Hospitals, Hillsborough Campus, and will remain open for 4 more years. Study involvement includes 4 study visits over a six month time period. Participants are given free medication, and compensation for their time.

Website

https://sites.duke.edu/updatestudy/

Texas

Texas Tech University Health Sciences Center (Midland, TX)
Subject

A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach

Contact

For more information please contact Jennifer R Hinojosa, RN, by phone 432-335-5113  or email  jennifer.hinojosa@ttuhsc.edu  

Requirements

The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.


Eligibility
Ages Eligible for Study:  
21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
Yes


Sampling Method:  
Non-Probability Sample


Study Population
All patients willing to participate, and give informed consent, and Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.
2—Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.
Pregnant women ages 21 to 75 years who are both asymptomatic and healthy Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition


Criteria
Inclusion Criteria:
All patients willing to participate, and give informed consent, and
Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.
Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.
Pregnant women ages 21 to 75 years who are both asymptomatic and healthy
Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition
Exclusion Criteria:
Asymptomatic patients ages < 21 or > 75, or symptomatic patients ages < 21 or > 75 years.
Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks
Patients unable to follow the protocol or unwilling to participate

Website

https://clinicaltrials.gov/ct2/show/NCT01829204?term=vulvodynia&rank=34

Virginia

McLean Center for Complementary and Alternative Medicine (Vienna, VA)
Subject

Effect of Two Acupuncture Protocols on Vulvodynia (Acu/Vul-pain)

Contact

For more information, or if you are interested in participating in this study, please contact Arthur Y Fan, MD (CHN), PhD by phone 703-499-4428 or email ArthurFan@ChineseMedicineDoctor.us

Requirements

You may be eligible to participate in this study if you are a women between the ages of 18 and 45, have been diagnosed with generalized and/or provoked vestibulodynia by an OB/GYN or pain specialist and have a current pain score higher than 4 with tampon insertion and removal, or cotton swab test at the initial screen test. Participants must be able to speak and read either English or Chinese.

This study evaluates acupuncture for the treatment of vulvodynia; specifically, if it reduces vulvar pain, pain duration and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. One-third of the women will receive acupuncture focused on pudendal nerve distribution area; another one-third of the women will receive acupuncture focused on traditional meridian points; the other one-third of women will receive standard care (without acupuncture). Women who experience a reduction in pain (included in subjective and objective scores) will have their pain monitored once a week for up to 6 weeks to see if the acupuncture effect lasts.

Exclusion Criteria:

1. infectious conditions of the vulva/vagina;
2. inflammatory conditions of the vulva/vagina;
3. neoplastic disorders of the vulva/vagina;
4. neurologic disorders of the vulva/vagina;
5. acute trauma to the genitals;
6. iatrogenic conditions of the genitals
7. hormonal deficiencies
8. co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
9. menopause
10. patients who have active migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia, in past 6 month.

Website

https://clinicaltrials.gov/ct2/show/study/NCT03481621#contacts

Virtual

Genito-Pelvic Pain Study at Capella University (Minneapolis, MN)
Subject

Persons with Vaginas who have Genito-Pelvic Pain and the Role it Plays in their Intimate Relationships with other Persons with Vaginas.

Contact

For additional information or if you are interested in participating, please contact Lindsey Fisher by email lfisher31@capellauniversity.edu or phone 480-788-1029 (text or call).

Requirements

Do you have a vaginal genito-pelvic pain condition, like vulvodynia or vaginismus? Are you currently or have you been in an intimate relationship with a person with a vagina in the last 3 years?


Lindsey Fisher is conducting research for her doctoral dissertation on persons with vaginas who have genito-pelvic pain and the role it plays in their intimate relationships with other persons with vaginas.


Seeking participants for study who meet these qualifications:
• Between 21-50 years old
• Presence of a genito-pelvic pain (GPP) condition
• Experienced GPP at least 4 times in the last year
• Experienced GPP at least once in the last 2 months
• Your GPP has affected your relationship(s)
• Have been in at least one intimate relationship with a person with a vagina in the last 3 years
• Have not experienced menopause
• Have ability to participate via Zoom video call


* Lindsey’s intent is to be as inclusionary as possible. The key population she is seeking includes queer women, non-binary, assigned female at birth, and trans persons with a vagina with a vaginal pain condition who are in a relationship with another person with a vagina.


Exclusions:
• Pain that can be attributed to a non-sexual, diagnosed medical condition, e.g., fibromyalgia.
• Persons who are experiencing or have had menopause.
• Outside of the age range of 21-50 years of age.
• Persons who have pain conditions, but it does not affect your relationship(s)


Study procedures: interview via Zoom
Time commitment required: 1 interview, approximately 1 hour; possible 2nd interview for follow-up and clarification, time may vary.

Website

https://lindseyafisher.wixsite.com/research

Canada

Quebec

Sherbrooke (Quebec, Canada)
Subject

Pelvic Floor Myofascia: A New Player Involved in Vulvodynia

Contact

For more information or to participate please contact Camille Simard, M.Sc. by phone 819-821-8000 ext 18439 or email labomorin@usherbrooke.ca
OR
Contact Mélanie Morin, P.T., Ph.D. by phone 819-821-8000 ext 13818 or email melanie.m.morin@usherbrooke.ca

Requirements

Study Population:
Asymptomatic controls (without any vulvar pain) and women suffering from provoked vestibylodynia (moderate to severe pain for at least 90% of the time when engaging in or attempting sexual intercourse) are being recruited.


Inclusion Criteria:


No pain during sexual intercourse (for the healthy women)
Moderate to severe pain (≥ 5/10) during sexual intercourse for at least 3 months (for women with provoked vestibulodynia)
Moderate to severe pain (≥ 5/10) at least 90% of the time when engaging in or attempting sexual intercourse for at least 3 months (for women with provoked vestibulodynia)


Exclusion Criteria:


Current or past pregnancy
Urogynecological condition (e.g., pelvic organ prolapse stage ≥ 3, urinary leakage, current urinary/vaginal infection or in the last 3 months)
Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
Post-menopausal state
Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, pelvic organ prolapse surgery)
Prior use of pelvic floor physiotherapy
Medication that could influence pain perception (e.g., analgesic, antidepressant)
Other medical conditions that could interfere with the study

Website

https://clinicaltrials.gov/ct2/show/NCT05350618?cond=vulvodynia&draw=2&rank=31

Abroad

Austria

Medical University of Graz (Graz, Austria)
Subject

Laser Therapy for Vulvodynia (Lydia)

Contact

For more information, please contact Gerda Trutnovsky, MD by phone +43 316 385 ext 81081 or email gerda.trutnovsky@medunigraz.at
or
contact Karl Tamussino, MD by phone +43 316 385 ext 81068 or email karl.tamussino@medunigraz.at

Requirements

Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:

-Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
-multidisciplinary treatment for at least 3 months
-Informed consent

Exclusion Criteria:

-Current genital infection (i.e. candidiasis, herpes )
-Inflammatory vulvar disease/ dermatosis (i.e. lichen sclerosus, lichen planus)
-Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease)
-Recent vulvar trauma (i.e. bleeding, erosion or ulceration)
-Pudendal neuralgia
-Pregnancy, delivery <6 months -Epilepsy or major neurologic or psychiatric morbidity -Active systemic infection -Previous treatment with ionizing radiation in the area to be treated -History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring) -Fever -Systemic or local autoimmune disorders -History of photosensitivity disorder

Website

https://clinicaltrials.gov/ct2/show/NCT04711369?cond=vulvodynia&draw=2&rank=1

Medical University of Graz (Graz, Austria)
Subject

Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain (AMALIA)

Contact

For more information, please contact: Gerda Trutnovsky, MD by phone +43 316 385 ext 81081 or email trutnovsky@medunigraz.at
OR
Contact Daniela Gold, MD by phone +43 316 385 ext 81437 or email daniela.gold@medunigraz.at

Requirements

Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No


Inclusion Criteria:
Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
multidisciplinary treatment for at least 3 months


Exclusion Criteria:
Pregnancy
Current malignancy
Major neurologic or psychiatric morbidity
Study participation in Lydia trial (Lasertherapy for vulvodynia)

Website

https://clinicaltrials.gov/ct2/show/NCT05324280?cond=vulvodynia&draw=3&rank=20

Norway

Oslo (Norway)
Subject

Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia – Randomized Clinical Trial (ProLoVe Study) (ProLoVe)

Contact

For more information or to participate please contact Slawomir Wojniusz, Phd by phone +47 419 26 564 or emaail slawomir@oslomet.no
OR
Contact Mette B Kaarbø, Msc by phone +47 974 11 669 or email metteboy@oslomet.no

Requirements

Ages Eligible for Study: 18 Years to 35 Years (Adult)
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Accepts Healthy Volunteers: No


Inclusion Criteria:
Clinical diagnosis of provoked vestibulodynia
Age: 18 to 35
Must understand Norwegian well enough to be able to complete questionnaires
Must be able to attend treatment in Oslo, Norway


Exclusion Criteria:
Active infection in the vulvar region
Dermatologic lesion in the vulvar region
Presence of diagnostically confirmed psychiatric condition that necessitate treatment by a medical specialist in psychiatry of clinical psychology

Website

https://clinicaltrials.gov/ct2/show/NCT04613713?cond=vulvodynia&draw=2&rank=49

Sweden

Uppsala (Uppland)
Subject

An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain

Contact

For more information or to participate, please contact Monica Buhrman, PhD by phone 0046184712126 or email monica.buhrman@psyk.uu.se

Requirements

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample


Study Population
People reporting diagnoses of endometriosis, vulvodynia, or fibromyalgia.


Inclusion Criteria:
-Age 18 or over
-Reporting diagnoses of endometriosis, vulvodynia, or fibromyalgia
-The pain condition present persistently or recurrently during ≥ 3 months
-Access to an internet-enabled smartphone/tablet
-Fluent in written Swedish


Exclusion criteria:
– Planned surgery during the upcoming 6 weeks

Website

https://clinicaltrials.gov/ct2/show/NCT05518630?cond=vulvodynia&draw=2&rank=54