National Vulvodynia Association

A Necessary Multi-Parametric Evaluation of Vulvodynia

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.

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.

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

Vestibulectomy Surgical Techniques Comparison Study

For more information or to participate in the study, please contact the Women’s Health Research Unit Confidential Recruitment Line by phone 503-494-3666 or email whru@ohsu.edu

Inclusion Criteria:
1. Reported provoked tenderness to the vestibule for at least 3 months in non-pregnant, estrogen-replete healthy subjects aged 18 years or over meeting Friedrich’s criteria for PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 for vulvar pain. Subjects who are >45years of age must have either a maturation index52 of < 10% parabasal cells or willingness to participate in local estrogen replacement until achieving this same clinical result.
2. Cotton swab Test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o’clock) and cotton swab test verbal score ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum
3. Ability to insert a regular Tampax® tampon
4. Baseline Tampon Test verbal pain score ≥430
5. Phone and internet access
6. Willingness to engage in pelvic floor physical therapy (PT)

Exclusion Criteria:
1. Pregnancy
2. Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus)
3. Unable or unwilling to complete baseline assessments
4. Prior vestibulectomy or hymen surgery
5. Prior or current use of testosterone dosed for gender affirmation

https://clinicaltrials.gov/study/NCT05343182?cond=vulvodynia&aggFilters=status:rec&rank=3

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

For more information please contact Ailena R Mulkey, RN, by email  ailena.mulkey@ttuhsc.edu  

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

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

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

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

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.

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

Laser Therapy for Vulvodynia (Lydia)

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

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

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

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

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

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)

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

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

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

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

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

Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia

For more informatoin or to participate in the study, please contact Andrzej Stepulak, Professor by phone 448 52 98 ext 0048 81 or email cwnr@umlub.pl

Inclusion Criteria:
1. Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion for testing).
2. Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study
3. Signing the patient’s informed and voluntary consent to participate in the study.
4. General health of the patient (WHO = 0-2).
5. Diagnosis of vulvodynia.
6. Negative drug test found at the visit randomization.
7. Documented correct cytology result from 3 years ago (before the visit screening).
8. Stable dose of drugs acting on the central nervous system used min. 1 month before the screening visit and during the entire patient’s participation in the study.
9. Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted.
10. The ability to understand the principles of testing and operating electronic devices.

Exclusion Criteria:
1. Severe, hepatic and renal dysfunction defined as:
i. An ASPT or ALT result 5 times the upper limit; ii. The level of bilirubin 3 times above the upper limit of normal – excluding patients with Gilbert’s syndrome; iii. EGFR result below 30 ml / min / m2, on the basis of historical studies not older than 3 years before the screening visit or from the tests performed during the screening visit according with point 12 of the Protocol, version 1.0 of March 28, 2022.
2. Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), and anticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from the screening visit.
4. Taking opioid drugs in the last 2 months before the screening visit (also in OTC preparations, eg Loperamide).
5. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life.
6. BTA injection in the vulva in the last 4 months before the screening visit. 7. Endovascular procedures in the area of the small pelvis in the last 6 months before the screening visit.
8. Previous surgical procedures requiring general anesthesia (with general anesthesia) in the last 2 months before the screening visit.
9. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in the last 4 months before the screening visit.
10. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and / or yeast infections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times / year).
11. Diagnosis of current or past serious mental disorders according to the criteria of ICD-10 and DSM-5, including psychotic and organic disorders (except depression and anxiety disorders).
12. Gynecological abnormalities requiring medical treatment: current HSIL, CIN II / III, pelvic inflammation, mixed or solid ovarian tumors, simple ovarian cysts greater than 5 cm, abnormal vaginal inter-cycle bleeding.
13. Pelvic venous diseases (PeVD), 4 criteria met on USG. 14. Pregnancy and lactation. 15. Spastic diseases: multiple sclerosis (MS), connective tissue diseases (Marfan syndrome and marfan-like syndromes), reactive arthritis (RA). 16. Vaginismus, Lamont scale 3-5 (gynecological examination impossible due to anxiety).
17. Significant and / or uncorrected disability in the field of sight or hearing, making it difficult to perform psychological tests.

https://clinicaltrials.gov/study/NCT05955313?cond=vulvodynia&aggFilters=status:rec&rank=9

An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain

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

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

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