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Vulvodynia clinical trials

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NCT ID: NCT03770169 Completed - Vulvodynia Clinical Trials

Validation of Patient Reported Outcome Measures for Use in Vulvodynia

Start date: February 18, 2019
Phase:
Study type: Observational

The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia

NCT ID: NCT03431779 Completed - Vestibulodynia Clinical Trials

Lipofilling as a Treatment for Vestibulodynia

Start date: April 17, 2018
Phase: N/A
Study type: Interventional

The investigators would like to investigate if lipofilling with its adipose derived stem cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than vestibulectomy. The investigators expect the study to be successful because of the anti-inflammatory effects of the ADSC and its effectiveness -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia or post mastectomy pain syndrome. Method: A controlled intervention study: one group receiving golden standard therapy 'vestibulectomy' and one group receiving vestibular lipofilling.

NCT ID: NCT03364127 Completed - Vulvodynia Clinical Trials

Effect of Acupuncture on Patient Vulvodynia Outcomes

Start date: February 23, 2018
Phase: N/A
Study type: Interventional

This study evaluates acupuncture for the treatment of vulvodynia; specifically if it reduces vulvar pain and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. Half of the women will receive acupuncture and the other half will receive placebo acupuncture. Women who get a reduction in pain will monitor there pain once a week for up to 12 weeks to see how long the acupuncture effect lasts.

NCT ID: NCT03197337 Completed - Vulvodynia Clinical Trials

Is Localized Provoked Vulvodynia Caused by Laxity of the Utero-Sacral Ligaments?

Start date: July 23, 2017
Phase: N/A
Study type: Interventional

Small-scale experiments conducted by our group have led to the hypothesis that Localized Provoked Vulvodynia (LPV) may be due to laxity of the Utero-Sacral ligaments (USL). According to this hypothesis, the pain experienced by women with LPV is due to the USL's inability to provide appropriate support for the pudendal nerve. In order to test this hypothesis we will conduct a single-blind randomized control trial in which patients with LPV will undergo a pressure-test - pressure will be temporarily applied to the posterior fornix using a large-sized applicator, thus strengthening the USL and adding support to the pudendal nerve. While the pressure is being applied, the cotton-swab test will be performed (palpating vulvar and vestibular sites using a cotton-swab), and each patient will rate the elicited pain on a scale of 1 to 10 (1 - not painful, 10 - worst pain imaginable). The results for each patient will be compared to their baseline level of pain (which will be recorded in the beginning of the experiment) and to the level of pain they report while inserting a speculum but not applying any pressure.

NCT ID: NCT02981433 Completed - Vulvodynia Clinical Trials

Vulvodynia: Identification of Potential Relevant Biomarkers

Start date: March 13, 2019
Phase:
Study type: Observational

Vulvodynia is a syndrome of unexplained vulvar pain that is frequently accompanied by physical disabilities, limitation of daily activities (such as sitting and walking), sexual dysfunction and psychologic disability. Originally suggested by McKay, the term "vulvodynia" has also been suggested by the International Society for the Study of Vulvar Disease Task Force to describe any vulvar pain. The incidence and prevalence of vulvodynia have not been well studied. Age distribution for the condition may range from the 20s to the 60s, and it is limited almost exclusively to white women. Obstetric and gynecologic history is usually unremarkable. Risk-taking sexual behavior is rare, and few patients have a history of sexually transmitted diseases. Vulvar pain usually has an acute onset, at times associated with episodes of vaginitis or certain therapeutic procedures of the vulva (cryotherapy or laser therapy). In most cases, vulvodynia becomes a chronic problem lasting months to years. Vulvar pain is frequently described as burning or stinging, or a feeling of rawness or irritation. Most patients consult several physicians before being diagnosed. Many are treated with multiple topical or systemic medications, with minimal relief. In some cases, inappropriate therapy may even make the symptoms worse. Since physical findings are few and cultures and biopsies are frequently negative, patients may be told that the problem is primarily psychologic, thus invalidating their pain and adding to their distress.

NCT ID: NCT02919813 Completed - Clinical trials for Provoked Localized Vulvodynia

M-gCBT for Women With Provoked Localized Vulvodynia

Start date: December 16, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a counseling technique that has been shown to reduce pain and anxiety with other medical conditions, including chronic pain conditions. The investigators wish to see if participation in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV greater than education alone. Both techniques use a group setting including other women with PLV. "Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized Vulvodynia" is a study designed to learn more about the use of mindfulness based group cognitive behavior therapy for PLV pain and anxiety over education alone. Participants will be randomized to one of two groups: mindfulness based cognitive behavior therapy or group education seminars.

NCT ID: NCT02892214 Completed - Clinical trials for Localized Provoked Vulvodynia

The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia

Start date: November 30, 2016
Phase:
Study type: Observational [Patient Registry]

The proposed study will evaluate how personality characteristics, cognitive factors and the emotional and behavioral responses of patients with provoked vestibulodynia (localized provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional health and sexual functioning.

NCT ID: NCT02858375 Completed - Vestibulodynia Clinical Trials

Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia

QUALVESTO
Start date: March 2013
Phase: N/A
Study type: Observational

The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.

NCT ID: NCT02858219 Completed - Vestibulodynia Clinical Trials

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

VESTIBULE
Start date: May 4, 2010
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT02809612 Completed - Vulvodynia Clinical Trials

An Internet-based Information Platform for Vulvodynia Patients

EMBLA
Start date: March 2016
Phase: N/A
Study type: Interventional

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.