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

McGill University (Online Study)
Subject

An Online Study on Clitorodynia

Contact

Mayte Parada
mayte.parada@mail.mcgill.ca
514-398-5323

Requirements

A group of researchers at McGill University is seeking women who experience clitoral pain (clitorodynia) to participate in an online study designed to collect demographic information, assess pain symptoms, and potential causes of this important women’s health issue. If you believe you suffer from this problem or have been diagnosed with clitorodynia and would like to participate we would like your help. Participation includes a 30-minute online questionnaire that includes demographic information, gynecological/medical history, and sexual functioning. No pain will be experienced or health risks posed. All personal information is strictly confidential and will not be shared with third parties. Participants will be entered into a raffle for one of two gift cards from amazon.com (odds are approximately 1 in 100).

Website

You can directly access the survey through the following link: http://goo.gl/ob2Zg.

United States

California

UCLA Center for Neurobiology of Stress (Los Angeles, CA)
Subject

UCLA Study Examining Brain Changes in Women with Vulvodynia

Contact

Anna Amamchyan, Clinical Research Coordinator
310-825-5255 or aamamchyan@mednet.ucla.edu

Requirements

Women between the ages of 18 and 55 who have been diagnosed with Vulvodynia or Provoked Vestibulodynia or are experiencing chronic pain at the vaginal opening with/without intercourse may be eligible to participate in this study. The purpose of this study is to help researchers understand the physiology and genetic makeup of this chronic pain condition in order to develop more effective treatments. Participation involves two visits over 1-2 weeks and includes a pelvic exam, muscle sensitivity testing, a small blood test, saliva sample, questionnaires, and MRI scans. Participants must not be pregnant. Participants can earn up to $170 and will receive a picture of their brain. This study is conducted by Dr. Andrea Rapkin in the UCLA Department of Obstetrics and Gynecology and Dr. Jennifer Labus at the UCLA Center for Neurobiology of Stress.

Website

(www.uclacns.org).

San Diego Sexual Medicine (San Diego, CA)
Subject

A double-blind placebo controlled prospective pilot study of visible changes in the vulva and vestibule post one cycle (3 treatments) of the vestibule with the MonaLisa Touch C)2 fractionated laser.

Contact

To learn more about the MonaLisa Touch laser treatment, and to see if you qualify for the clinical trial, please call SDSM at 619-265-8865.

Requirements

Are you experiencing pain with intimacy?
Is wearing pants uncomfortable?
Do you have burning or discomfort in the external genital region?
If you are a woman between 21 and 80 and answered yes to any of these questions, you may have vestibulodynia or vulvodynia, and be eligible to participate in a clinical trial with an FDA cleared device.

Illinois

Northwestern University Feinberg School of Medicine (Chicago, IL)
Subject

Open Ended Chart Review of Adult Women Presenting to the Vulvar Mucosal Specialty Clinic at Northwestern University Department of Dermatology

Contact

For more information please contact:
Bethanee J Schlosser, MD, PhD, by phone 312-695-8106 or email bschloss@nm.org
Aleksandra G Florek, MD, by phone 312-695-3613 or email aleksandra.florek@northwestern.edu

Requirements

Purpose
This study aims to develop a clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in management of vulvar disease.


Eligibility
Ages Eligible for Study:  
18 Years and older   (Adult, Senior)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No


Sampling Method:  
Probability Sample


Study Population
Women seen at the Vulvar Mucosal Specialty Clinic


Criteria
Inclusion Criteria:
Patients 18 years of age or older
Patients seen at Northwestern Medical Group Department of Dermatology who were seen by Dr. Bethanee Schlosser and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings.
Exclusion Criteria:
Patients who refuse complete mucocutaneous examination.
Patients who refuse recommended diagnostic procedures.
Pregnant women or prisoners.

Website

https://clinicaltrials.gov/ct2/show/NCT02881229?term=vulvodynia&rank=45

Maryland

University of Maryland School of Nursing
Subject

The purpose of the study is to evaluate neurosensory and psychological associations with vulvodynia.

Contact

Please contact Valerie Dernetz, RN by telephone at (410) 706-8247 or by email at vdernetz@umaryland.edu.

Requirements

Women over the age of 21 with a diagnosis of vulvodynia, vestibulitis, or vestibulodynia who are able to speak and read English are eligible to participate. The study requires one 2 to 3 hour visit. During this time, you will be asked to answer a health history questionnaire and two questionnaires focused on feelings and behaviors associated with the experience of pain. Then, you will undergo non-invasive assessments which measure the function of your sensory nerves in your forearm, shoulder, and vulva. Lastly, there will be a single blood draw. Participants will receive a $75 Visa gift card and a parking voucher.

Michigan

Beaumont Hospitals (Royal Oak, MI)
Subject

A double-blinded, randomized study to compare onobotulinumtoxin A vs. Kenalog for intravaginal trigger point injections in the treatment of chronic pelvic pain

Contact

For more information please contact Amanda Schonhoff, RN, BSN, by phone 248-551-1225 or email amanda.schonhoff@beaumont.org

Requirements

The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).


Eligibility
Ages Eligible for Study:  
18 Years and older   (Adult, Senior)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No
Criteria
Inclusion Criteria:
Provide informed consent
Healthy women > age 18 regardless of menopausal status
Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist.
High-tone pelvic floor dysfunction on vaginal exam
A pelvic pain score of > 4 on screening VAS
Pain perceived to be in the pelvis that has been present for at least 3 months.
Exclusion Criteria:
Patients that have had Botox to the bladder within the last 8 months
Patients that have had Botox outside the bladder of > 160 u within the last 12 weeks.
Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months
Pregnancy
Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators.
Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication.
Systolic blood pressure > 160 mm Hg on screening blood pressure
Heart rate > 110 beats/minute on screening heart rate

Website

https://clinicaltrials.gov/ct2/show/NCT02369068

North Carolina

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

Peripheral and Central Mechanisms of Vulvar Vestibulitis Syndrome (VVS)

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 20 and 50 who have been diagnosed with vulvar vestibulitis syndrome and/or experience pain in the vaginal region upon contact, as well as women with no prior history of pain with intercourse or pain on contact, may be eligible to participate in this study. Participants must be premenopausal and cannot be pregnant. Participation involves undergoing sensory testing and a modified gynecological exam. It will require 1 visit at UNC School of Dentistry and 1 visit at UNC Women’s Hospital. Participants will receive up to #130 for complete participation. The purpose of this research study is to learn how VVS develops so that in the future, better treatments can be found.

Website

http://www.med.unc.edu/ppru/research/current-research-1/participating-in-research

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

Postpartum Pain

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 20 and 50 who currently have vaginal pain upon contact after child birth, may be eligible to participate in this study. Women must be premenopausal and cannot be pregnant. Participation involves undergoing sensory testing and modified gynecological exams. It will require 2 visits to the University of North Carolina over the course of 2 weeks. The purpose of this research is to further the understanding of post partum dyspareunia in an effort to lessen the impact of maternal morbidity on early parenting, family dynamics and health care costs.

Website

http://www.med.unc.edu/ppru/research/current-research-1/postpartum

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

Oregon

Oregon Health and Science University (Portland, OR)
Subject

Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized Vulvodynia

Contact

To find out more information and to learn if you are qualified to participate, please complete the online form http://www.ohsu.edu/xd/health/services/women/clinical-trials/contact-us.cfm or contact the Women’s Health Research Unit’s confidential recruitment line at 503-494-3666.

Requirements

You may be eligible to participate in the study if you are a woman 18 years of age or older, able to come to OHSU once a week for 8 weeks, and you have been diagnosed with provoked localized vulvodynia, also known as vulvar vestibulitis or provoked vestibulodynia.

Participants will be randomized to one of two groups: mindfulness based cognitive behavior therapy or group education seminars. This study involves 8 visits over 8 weeks. Participants will visit the OHSU Center for Women’s Health at the Kohler Pavilion on Marquam Hill for study visits, which include study sessions and several questionnaires. Participants will receive usual treatment for provoked localized vulvodynia, mindfulness based group cognitive behavior therapy or group education seminars and be asked to complete a tampon test every week, and a pain diary every day.

The purpose of this study is to learn more about how to reduce pain and distress associated with PLV. Specifically, learning more about Mindfulness Based Group Cognitive Behavior Therapy (M-gCBT) compared to education alone as a treatment for the distress and pain associated with PLV. M-gCBT is a counseling technique that has been shown to reduce pain and anxiety with other medical conditions. They wish to see if participation in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV.

Qualified participants will receive 8 sessions (either mindfulness based cognitive behavior therapy or group education seminars) with licensed practitioner(s) free of charge.

Principal Investigator: Catherine Leclair, MD

Pennsylvania

Pelvic and Sexual Health Institute (Philadelphia, PA)
Subject

Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Contact

For more information please contact Elizabeth Elias, CCRP, by phone 267 479 2387 or email InterStimStudy@yahoo.com

Requirements

Purpose:
To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).


Eligibility
Ages Eligible for Study:  
18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No


Criteria
Inclusion Criteria:
Female with diagnosis of IC/PBS with implanted IPG Interstim.
Scores > 8 on the Interstitial Cystitis Symptom index questionnaire (ICSI) and > 8 on the Interstitial Cystitis Problem Index questionnaire (ICPI).
Signed Informed Consent.
Exclusion Criteria:
Progressive neurologic disease or peripheral neuropathy.
History of bladder surgery.
Subjects implanted with other neuromodulation device.
Current or planning pregnancy; Breastfeeding.
Subjects who are not deemed able to fill questionnaires
Mental illness or mentally unstable patients

Website

https://clinicaltrials.gov/ct2/show/NCT01312259?term=vulvodynia&rank=43

Center for Pelvic Medicine (Philadelphia, PA)
Subject

A double-blind placebo controlled prospective pilot study of visible changes in the vulva and vestibule post one cycle (3 treatments) of the vestibule with the MonaLisa Touch C)2 fractionated laser.

Contact

To learn more about the MonaLisa Touch laser treatment, and to see if you qualify for the clinical trial, please call 610-525-0541.

Requirements

Are you experiencing pain with intimacy?
Is wearing pants uncomfortable?
Do you have burning or discomfort in the external genital region?
If you are a woman between 21 and 80 and answered yes to any of these questions, you may have vestibulodynia or vulvodynia, and be eligible to participate in a clinical trial with an FDA cleared device.

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

Washington DC

MedStar Washington Hospital Center (Washington, DC)
Subject

Clinical Trial Comparing the Safety and Efficacy of Clobetasol Proprionate (Temovate) to the Mona Lisa Radiofrequency C02 Laser in Treatment of Symptomatic Lichen Sclerosus.

Contact

For more information, please visit:
(https://clinicaltrials.gov/ct2/show/NCT02573883?term=NCT02573883&rank=1).

Primary Investigator: Dr.Cheryl Iglesia, Cheryl.Iglesia@medstar.net, 202-877-6526
Research Coordinator: Joanna Peterson, Joanna.L.Peterson@medstar.net, 202-877-0526

Requirements

If you are a postmenopausal women who has been diagnosed with Lichen Sclerosus, and bothered by symptoms such as vulvar itching, discomfort, bleeding or blisters, you may be eligible to participate in this study. Participants must speak and read english and be able to attend 5 clinic appointments at MedStar Washington Hospital Center/National Center for Advanced Pelvic Surgery in Washington DC. You cannot be enrolled in the study if you have history of gynecologic malignancy, pelvic radiation, active genital infection, severe pelvic organ prolapse, or vaginal mesh.


If you qualify, you will be randomized to treatment with Clobetasol Proprionate or C02 radiofrequency laser therapy. You will be asked to complete questionnaires about your symptoms. Participants will pay the standard rate for a clinic visit but will not be charged for the laser treatment. Participants will receive a $30 Target gift card at the end of trial participation.


Location: Medstar Washington Hospital Center, Female Pelvic Medicine and Reproductive Surgery Office Washington, DC

Canada

British Columbia

University of British Columbia (Vancouver, BC)
Subject

Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Contact

For more information please contact Marcy L Dayan, BSc Rehab, by phone 604-739-3133 or email dayanphysio@telus.net

Requirements

Purpose
Hypothesis:
Specific physiotherapy interventions will decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastrophizing behaviour in women with provoked vulvar vestibulodynia. This study will look at specific physiotherapy treatment interventions to see if they decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastophizing behaviour. Participants will fill out a questionnaire on their pain symptoms and complete standardized scales prior to starting treatment and after 4 sessions to determine change due to interventions.
A combination of physiotherapy, group educational sessions and group cognitive behavioural therapy will have better outcomes than physiotherapy alone.
Results of physiotherapy intervention alone will be compared to results of those treated with physiotherapy, group educational sessions and group cognitive behavioural therapy at a separate treatment centre. Physiotherapy interventions and outcome measures are the same between both groups.
Justification:
Standard treatment is hard to identify as many approaches are taken, none with any evidence to support them. This study aims to look at specific techniques (pelvic floor coordination and relaxation exercises, education on female sexual response and pain pathophysiology education) to see if there is a benefit.


Eligibility
Ages Eligible for Study:  
16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No


Criteria
Inclusion Criteria:
40 years and under
diagnosis of provoked vulvar vestibulodynia
Exclusion Criteria:
early menopause
have had a total or partial hysterectomy
are on estrogen suppression medication
have a primary arousal disorder
declined admission to the Multidisciplinary Vulvodynia Program at Vancovuer General Hospital

Website

https://clinicaltrials.gov/ct2/show/NCT01628679?term=vulvodynia&rank=33

Nova Scotia

Dalhousie University (Halifax, Nova Scotia, Canada)
Subject

A Comparison of Cognitive-Behavioural Couple Therapy and Lidocaine in the Treatment of Provoked Vestibulodynia: A Randomized Clinical Trial.

Contact

Kathy Petite, Research Coordinator
902-494-4223 or pvdstudies@dal.ca

Requirements

The Couples & Sexual Health Laboratory (Dalhousie University) and the Women’s Sexual Health Laboratory (Université de Montréal) are currently recruiting couples in which the woman experiences pain during sexual intercourse for a treatment study. The purpose of this randomized clinical trial is to evaluate the efficacy of a recently developed, 12-week couples therapy (Cognitive-Behavioral Couple Therapy) for women suffering from vulvodynia and one of the most commonly prescribed front-line medical interventions, (i.e., topical lidocaine). As participants in this research project, women suffering from pain during sexual intercourse will take part in a diagnostic gynecological examination, and couples will take part in structured interviews and complete questionnaires. Eligible couples that agree to participate will be randomly assigned to one of the two treatment options, and will be asked to complete self-report questionnaires and structured interviews following completion of the treatment, as well as 6-months after treatment completion. This project is approved by the IWK Health Centre Research Ethics Board and the Research Ethics Committee of CHUM and the Faculty of Arts and Sciences of the Université de Montréal, and is funded by the Canadian Institutes of Health Research.

Dalhousie University (Halifax, Nova Scotia, Canada)
Subject

Interpersonal Goals in Women with Vulvodynia and their Partners: A Daily Experience Study.

Contact

Kathy Petite, Research Coordinator
902-494-4223 or pvdstudies@dal.ca

Requirements

The Couples & Sexual Health Laboratory (Dalhousie University) and the Women’s Sexual Health Laboratory (Université de Montréal) are currently recruiting couples in which a woman suffers from vulvovaginal pain. The purpose of this research is to evaluate the impact of interpersonal sexual goals between both partners on women’s pain, as well as the impact upon the psychological and sexual adjustment of each member in the couple. As participants in this research project, women suffering from pain during sexual intercourse will take part in a diagnostic gynecological examination, and couples will take part in structured interviews and complete questionnaires. Eligible couples that agree to participate shall complete daily journals on the Internet for a period of two months. Financial compensation is provided. This project is approved by the IWK Health Centre Research Ethics Board and the Research Ethics Committee of CHUM and the Faculty of Arts and Sciences of the Université de Montréal, and is funded by the Canadian Institutes of Health Research.

Quebec

Université de Montréal (Montreal, Quebec, Canada)
Subject

Interpersonal Goals in Women with Vulvodynia and their Partners: A Daily Experience Study.

Contact

Mylène Desrosiers, Research Coordinator
514-343-6111 ext. 37428 or info@sophiebergeron.ca

Requirements

The Women’s Sexual Health Laboratory (Université de Montréal) and the Couple & Sexual Health Laboratory (Dalhousie University) are currently recruiting couples in which the woman suffers from vulvovaginal pain. The purpose of this research is to evaluate the impact of interpersonal sexual goals between both partners on women’s pain, as well as the impact upon the psychological and sexual adjustment of each member in the couple. As participants in this research project, women suffering from pain during sexual intercourse will take part in a diagnostic gynecological examination, and couples will take part in structured interviews and complete questionnaires. Eligible couples that agree to participate shall complete daily journals on the Internet for a period of two months. Financial compensation is provided. This project is approved by the Research Ethics Committee of CHUM and the Faculty of Arts and Sciences of the Université de Montréal and the IWK Health Centre Research Ethics Board, and is funded by the Canadian Institutes of Health Research.

Université de Montréal (Montreal, Quebec, Canada)
Subject

A Comparison of Cognitive-Behavioural Couple Therapy and Lidocaine in the Treatment of Provoked Vestibulodynia: A Randomized Clinical Trial.

Contact

Mylène Desrosiers, Research Coordinator
514-343-6111 ext. 37428 or info@sophiebergeron.ca

Requirements

The Women’s Sexual Health Laboratory (Université de Montréal) and Couple & Sexual Health Laboratory (Dalhousie University) are currently recruiting couples in which the woman experiences pain during sexual intercourse for a treatment study. The purpose of this randomized clinical trial is to evaluate the efficacy of a recently-developed, 12-week couples therapy (Cognitive-Behavioral Couple Therapy) for women suffering from vulvodynia and one of the most commonly prescribed front-line medical interventions, (i.e., topical lidocaine). As participants in this research project, women suffering from pain during sexual intercourse will take part in a diagnostic gynecological examination, and couples will take part in structured interviews and complete questionnaires. Eligible couples that agree to participate will be randomly assigned to one of the two treatment options, and will be asked to complete self-report questionnaires and structured interviews following completion of the treatment, as well as 6-months after treatment completion. This project is approved by the Research Ethics Committee of CHUM and the Faculty of Arts and Sciences of the Université de Montréal and the IWK Health Centre Research Ethics Board, and is funded by the Canadian Institutes of Health Research.

Abroad

Brazil

University of Campinas (Campinas, Sao Paulo, Brazil)
Subject

Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial

Contact

For more information please contact Marcela G Bardin, by phone 5519981548688 or email mabardin@yahoo.com.br

Requirements

Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a negative impact over quality of life in women with this diagnose. The existing treatments, however, are manifold but insufficient. This study aims to verify the effectiveness of kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia. METHODS: A single-blind randomized controlled trial will examine 58 women, divided into three treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline), amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline hydrochloride associated with electrotherapy (interferential current). Exclusion criteria are: presence of infections or genital cancers, chronic degenerative diseases; younger than 18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride and being pacemakers use. The parameters analyzed before and after treatment will be: muscle volume of the anus elevator and perfusion of the pudendal artery obtained with 3D ultrasound, subjective pain in vaginal intercourse (visual analog scale), monthly frequency of vaginal intercourse, pain referred within vulvar touch on physical examination (swab test from zero to 10) and female sexual function (Female Sexual Function questionnaire – FSFI). There will be a follow up of subjective pain in vaginal intercourse and monthly frequency of vaginal intercourse obtained by telephone contact with the voluntary on one, six and twelve months after the end of interventions. The data will be analyzed using Chi-square test of Pearson, Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared using the Wilcoxon test (related samples) and McNemar (effect of the intervention), considering statistical significance level of 5%. The software used is the statistical analysis software (SAS) – Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003 and Statistical Package for the Social Sciences (SPSS) -Release 17.0.

Website

https://clinicaltrials.gov/ct2/show/NCT02871661?term=vulvodynia&rank=10

Croatia

University of Zagreb (Zagreb, Croatia)
Subject

The Diagnostic Accuracy of “Three Rings Vulvoscopy” for Detection of Vulvar Dermatosis (DATRIV)

Contact

For more information please contact Vesna Harni, MD, by phone 0038512923648 or email vesnaharni@gmail.com

Requirements

The purpose of this study is to determine the sensitivity and specificity of “Three Rings Vulvoscopy” for detection of vulvar dermatosis using histopathology as the reference standard.


Eligibility
Ages Eligible for Study:  
Child, Adult, Senior
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
Yes


Sampling Method:  
Non-Probability Sample


Study Population
Patients with vulvar discomfort recruited in colposcopy unit in “Poliklinika Harni”, a secondary care gynecologic clinic in Zagreb.
Patients without vulvar discomfort recruited from the group of patients undergoing planned labiaplasty, at the same location.


Criteria
Inclusion Criteria:
“Three Rings Vulvoscopy” performed at Poliklinika Harni, during the period from December 2011 – December 2016.
Ability to provide Informed Consent and complete Questionnaire.
Exclusion Criteria:
Incomplete medical records. Lack of histopathology. Vulvo-vaginal infection. Benign tumors of the vulva. Pre-/malignant conditions of the vulva.

Website

https://clinicaltrials.gov/ct2/show/NCT02732145?term=vulvodynia&rank=26

France

Hôpital Tenon (Paris, France)
Subject

A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia (VESTIBULE)

Contact

For more information contact Frédérique Lebreton, MD, by email frederique.lebreton@tnn.aphp.fr   

Requirements

The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.


Eligibility
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No


Criteria
Inclusion Criteria:
Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
Negative screening test results
Notified associated factors
Menopause, surgically sterilized women or women using effective contraceptive method
Good understanding and predictable adherence to the protocol
beneficiary/affiliated to French social security/social healthcare
signed Informed Consent Form
Exclusion Criteria:
Predictable poor adherence
Pregnant or breastfeeding women
Myasthenia
Treatment with aminoglycosides
Major mental disorders
Underlying etiology
Vulnerable subjects (particularly adults under guardianship)
Any reason deemed relevant by the investigator
Current or former (in the last 3 months) participation to another clinical trial

Website

https://clinicaltrials.gov/ct2/show/NCT02858219?term=vulvodynia&rank=51

Centre Hospitalier Universitaire de Besancon (Besançon, France)
Subject

A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia (CAPSIVU)

Contact

For more information please contact Fabien Pelletier, MD, by email fabien.pelletier@univ-fcomte.fr  

Requirements

This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.


Eligibility
Ages Eligible for Study:  
18 Years to 65 Years   (Adult)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No


Criteria
Inclusion Criteria:
Provoked vulvodynia, rated B2a according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification
Pain ≥ 4 on Visual Analogic Scale (VAS)
Subject refractory to at least 2 conventional treatments (tricyclic antidepressants, anticonvulsants at analgesic doses , biofeedback physical therapy, psychological assessment in a context of chronic pain) or to botulinum toxin A
If a former treatment with botulinum toxin A was performed: patient must be in treatment failure (= no decrease over 50% of the pain 3 months after initiation of the treatment)
Negative screening test results
Menopause, surgically sterilized women or women using effective contraceptive method
Good understanding and predictable adherence to the protocol
Beneficiary/affiliated to French social security/social healthcare
Signed Informed Consent Form
Exclusion Criteria:
Predictable poor adherence
Pregnant or breastfeeding women
Diabetes mellitus type 1 or type 2
Major mental disorders
Underlying etiology such as chronic vulvar disease
Initial vulvar erythema
Vulnerable subjects (particularly adults under guardianship)
Ongoing medical treatment with tricyclic antidepressants or anticonvulsants at analgesic doses
Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines doses analgesics, physiotherapy type of biofeedback)
Good understanding and predictable adherence to the protocol beneficiary/affiliated to French social security/social healthcare signed Informed Consent Form

Website

https://clinicaltrials.gov/ct2/show/NCT02854670?term=vulvodynia&rank=42

Centre Hospitalier Universitaire de Besancon (Besançon, France)
Subject

A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia (VESTIBULE)

Contact

For more information contact Fabien Pelletier,MD, by email fabien.pelletier@univ-fcomte.fr  

Requirements

The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.


Eligibility
Ages Eligible for Study:  
18 Years to 60 Years   (Adult)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No


Criteria
Inclusion Criteria:
Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
Negative screening test results
Notified associated factors
Menopause, surgically sterilized women or women using effective contraceptive method
Good understanding and predictable adherence to the protocol
beneficiary/affiliated to French social security/social healthcare
signed Informed Consent Form
Exclusion Criteria:
Predictable poor adherence
Pregnant or breastfeeding women
Myasthenia
Treatment with aminoglycosides
Major mental disorders
Underlying etiology
Vulnerable subjects (particularly adults under guardianship)
Any reason deemed relevant by the investigator
Current or former (in the last 3 months) participation to another clinical trial

Website

https://clinicaltrials.gov/ct2/show/NCT02858219?term=vulvodynia&rank=51

Ireland

Cork University Maternity Hospital and Cork Womens Clinic (Cork, Ireland)
Subject

To Investigate the Use of Trans-perineal Trigger Point Dry Needling With Manual Therapy and to Compare the Outcome With Manual Therapy Treatment for Chronic Pelvic Pain With Dyspareunia. A Randomized Clinical Trial.

Contact

For more information please contact:
Suzanne O’Sullivan, Dr,  by phone 021 4348931 ext 00353 or email Suzanne.OSullivan1@hse.ie   
Shalini Wiseman, BscPT, by phone 0861616236 ext 00353 or email shaliniwiseman@gmail.com   
Liz Barry, BscPT, by phone 0214920567 ext 00353 or email liz.barry1@hse.ie  

Requirements

Purpose
Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other pathology exists. The effectiveness of manual therapy in studies have shown statistically significant pre and post treatment differences.However no study has reviewed the efficacy of inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD. This study will investigate the effectiveness of trans-perineal trigger point dry needling used with manual therapy techniques for CPP.


Eligibility
Ages Eligible for Study:  
18 Years to 60 Years   (Adult)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
Yes


Criteria
Inclusion Criteria:
Patients reporting non-cyclical CPP with dyspareunia and associated PFD with no palpable pelvic floor pathology, but with palpable high pelvic floor muscle (PFM) tone and tenderness will be referred for physiotherapy by the gynaecology team.
Visceral conditions like interstitial cystitis are difficult to exclude at gynaecology review, as they mimic CPP symptoms.
Smokers and non-smokers included.
Nulliparous, singleton and multiparous patients.
Exclusion Criteria:
Body mass index greater than 30, makes it difficult to dry needle as the required needle length is not available.
Chronic back pain over 6 months duration, under pain management team.
Orthopaedic back surgeries with implants.
Pelvic pathologies like endometriosis, fibroids, cysts, etc.
Pregnancy related pelvic pain.
Pregnant during the trial.
Pelvic organ carcinomas.
Undergoing cancer treatment.
Post gynaecology surgeries, less than 16 weeks.
Cardiovascular, gastroenterology, renal or orthopaedic surgery, less than 6 month’s post-operative.
Neurological conditions like stroke, epilepsy, Parkinson’s disease etc.
Exclusion criteria for dry needling:
Extreme needle phobia, Rheumatoid arthritis, prolonged corticosteroid treatment, warfarin treatment, heart implants and blood clotting disorders.
Participant with no significant learning disability and should be able to understand the procedure to consent for treatment.
Participant should not require a chaperone during treatment.

Website

https://clinicaltrials.gov/ct2/show/NCT02795026?term=vulvodynia&rank=49

Israel

Ramat Eshkol Women health center, Clalit health Services (Jerusalem, Israel )
Subject

Subtypes of Provoked Vestibulodynia: A Prospective Study to Evaluate a Diagnostic Algorithm in Regard to Different Treatment Modalities

Contact

For more information please contact Ahinoam Lev-Sagie, MD, by phone +972-8-9762666 or email levsagie@netvision.net.il

Requirements

The proposed study will evaluate a clinical algorithm for the diagnosis and treatment of provoked vestibulodynia (PVD). The algorithm, distinguishes between four subtypes of PVD: hormonally mediated PVD, hypertonic pelvic floor dysfunction, congenital neuroproliferative PVD and acquired neuroproliferative PVD, based on a patient’s history and physical exam. The study will follow patients diagnosed with PVD, for one year, and evaluate the treatment outcome in the different subgroups. Investigators hope that conducting a prospective study, showing clinical benefit and improved outcome for patients classified according to this method may change the common practice of “trial and error” based treatment, and will improve clinical results.


Eligibility
Ages Eligible for Study:  
18 Years to 40 Years   (Adult)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
Yes


Sampling Method:  
Probability Sample


Study Population
Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem.


Criteria
Inclusion Criteria:
A history of 3 months or more of vulvar pain suggestive of PVD, i.e. symptoms of pain on vaginal penetration (insertional dyspareunia and/or pain with tampon insertion).
On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.
Exclusion criteria:
other causes for vulvar pain
pregnancy or a planned pregnancy in the upcoming year
unprovoked or mixed vulvodynia.

Website

https://clinicaltrials.gov/ct2/show/NCT02712814?term=vulvodynia&rank=32

Portugal

Centro Hospitalar de S. João EPE (Porto, Portugal)
Subject

An Open-label Study to Investigate the Effectiveness in Clinical Symptomatic Control and Tolerability of Medical Device LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses

Contact

For more information please call +351 – 225 512 100 or contact José Martinez de Oliveira, MD, PhD by phone +351 917 577 343 or email jmo@fcsaude.ubi.pt

Requirements

The current study aims to investigate the effectiveness in clinical symptomatic control and tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar dermatoses.


Eligibility
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No


Criteria
Inclusion Criteria:
Able and willing to give written informed consent.
Woman, with 18 or more years.
Diagnosed with symptomatic non-hypertrophic chronic vulvar dermatoses.
A pruritus score of at least 20 on a 100-mm VAS-PR.
Willing and able to comply with the study requirements.
Participant of childbearing potential agrees to remain abstinent or to use an acceptable contraceptive measure for the entire duration of the study.
Participant not of childbearing potential (e.g., is not sexually active, whose current partner is not of reproductive potential).
Exclusion Criteria:
Received systemic immunosuppressant therapy (e.g. systemic corticosteroids) within 4 weeks prior to admission.
Treated with daily topical therapy (e.g. topical corticosteroids, pimecrolimus, and tacrolimus) at the target vulvar area within 2 weeks prior to admission, which in the opinion of the investigator might compromise study results.
Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
Suffers from systemic or generalized infections (bacterial, viral or fungal).
Diagnosis of psoriasis, candidiasis, vulvar intraepithelial neoplasia or carcinoma of the vulva.
Pregnancy or breastfeeding.
Documented and consistent history of hypersensitivity reactions to similar topical products.
Any condition that in the opinion of the investigator might prevent the subject from completing the study or interfere with the interpretation of the study results.

Website

https://clinicaltrials.gov/ct2/show/NCT02541721?term=vulvodynia&rank=64

Centro Hospitalar Cova da Beira EPE (Covilhã, Castelo Branco, Portugal)
Subject

An Open-label Study to Investigate the Effectiveness in Clinical Symptomatic Control and Tolerability of Medical Device LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses

Contact

For more information please call +351 – 275 330 000 or contact José Martinez de Oliveira, MD, PhD by phone +351 917 577 343 or email jmo@fcsaude.ubi.pt

Requirements

The current study aims to investigate the effectiveness in clinical symptomatic control and tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar dermatoses.


Eligibility
Ages Eligible for Study:  
18 Years and older   (Adult, Senior)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No


Criteria
Inclusion Criteria:
Able and willing to give written informed consent.
Woman, with 18 or more years.
Diagnosed with symptomatic non-hypertrophic chronic vulvar dermatoses.
A pruritus score of at least 20 on a 100-mm VAS-PR.
Willing and able to comply with the study requirements.
Participant of childbearing potential agrees to remain abstinent or to use an acceptable contraceptive measure for the entire duration of the study.
Participant not of childbearing potential (e.g., is not sexually active, whose current partner is not of reproductive potential).
Exclusion Criteria:
Received systemic immunosuppressant therapy (e.g. systemic corticosteroids) within 4 weeks prior to admission.
Treated with daily topical therapy (e.g. topical corticosteroids, pimecrolimus, and tacrolimus) at the target vulvar area within 2 weeks prior to admission, which in the opinion of the investigator might compromise study results.
Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
Suffers from systemic or generalized infections (bacterial, viral or fungal).
Diagnosis of psoriasis, candidiasis, vulvar intraepithelial neoplasia or carcinoma of the vulva.
Pregnancy or breastfeeding.
Documented and consistent history of hypersensitivity reactions to similar topical products.
Any condition that in the opinion of the investigator might prevent the subject from completing the study or interfere with the interpretation of the study results.

Website

https://clinicaltrials.gov/ct2/show/NCT02541721?term=vulvodynia&rank=64

Apomédica - Serviços Médicos Ltd (Póvoa de Varzim, Porto, Portugal)
Subject

An Open-label Study to Investigate the Effectiveness in Clinical Symptomatic Control and Tolerability of Medical Device LabiaStick#01 in Subjects With Symptomatic Non-hypertrophic Chronic Vulvar Dermatoses

Contact

For more information please call +351 – 252 688 183  or contact José Martinez de Oliveira, MD, PhD by phone +351 917 577 343 or email jmo@fcsaude.ubi.pt

Requirements

The current study aims to investigate the effectiveness in clinical symptomatic control and tolerability of LabiaStick#01 in women with symptomatic non-hypertrophic chronic vulvar dermatoses.


Eligibility
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No


Criteria
Inclusion Criteria:
Able and willing to give written informed consent.
Woman, with 18 or more years.
Diagnosed with symptomatic non-hypertrophic chronic vulvar dermatoses.
A pruritus score of at least 20 on a 100-mm VAS-PR.
Willing and able to comply with the study requirements.
Participant of childbearing potential agrees to remain abstinent or to use an acceptable contraceptive measure for the entire duration of the study.
Participant not of childbearing potential (e.g., is not sexually active, whose current partner is not of reproductive potential).
Exclusion Criteria:
Received systemic immunosuppressant therapy (e.g. systemic corticosteroids) within 4 weeks prior to admission.
Treated with daily topical therapy (e.g. topical corticosteroids, pimecrolimus, and tacrolimus) at the target vulvar area within 2 weeks prior to admission, which in the opinion of the investigator might compromise study results.
Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
Suffers from systemic or generalized infections (bacterial, viral or fungal).
Diagnosis of psoriasis, candidiasis, vulvar intraepithelial neoplasia or carcinoma of the vulva.
Pregnancy or breastfeeding.
Documented and consistent history of hypersensitivity reactions to similar topical products.
Any condition that in the opinion of the investigator might prevent the subject from completing the study or interfere with the interpretation of the study results.

Website

https://clinicaltrials.gov/ct2/show/NCT02541721?term=vulvodynia&rank=64

Sweden

Akademiska Hospital (Uppsala, Sweden)
Subject

The EMBLA Project – An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients

Contact

For more information please contact Alkistis Skalkidou, MD, PhD, by phone 046-186110000 or email alkistis.skalkidou@kbh.uu.se

Requirements

Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological condition that leads to extreme suffering for both the women involved but also their partners. It has also been shown to be associated with poor quality of life, leading to depression and anxiety states. When left untreated, the condition takes a very long time to resolve, with a substantial associated disability and suffering. Both psycho-education and internet-based interventions have been shown to be highly successful while they can be quite affordable. This makes them highly cost-effective. The present study aims at evaluating the effectiveness of such an intervention among a vulvodynia patient population from the clinics of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians and given access to the internet-based platform, where they will fill out questionnaires during four different time-points, after randomization to the control or the intervention group. The intervention group will also have access to multiple activities and information material uploaded in the internet-based platform. Differences in pain, quality of life and mental health parameter outcomes will be assessed at the end of the study. Should this intervention prove effective, it will be implemented in clinical praxis in the four regions.


Eligibility
Ages Eligible for Study:  
Child, Adult, Senior
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
Yes


Criteria
Inclusion Criteria:
Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study
Exclusion Criteria:
inability to read and understand Swedish
severe mental illness
currently in treatment for vulvodynia

Website

https://clinicaltrials.gov/ct2/show/NCT02809612?term=vulvodynia&rank=5