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Vulvodynia clinical trials

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NCT ID: NCT01455350 Completed - Vestibulodynia Clinical Trials

Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Start date: October 2011
Phase: N/A
Study type: Interventional

Chronic gynaecological pain is a major medical problem that affects 20-30% of women at different moments of their life. This largely neglected issue has a significant impact on the sexual and conjugal life of women suffering from it as well as on their psychological health. Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally ignored. Also, treatment is limited and not extensively studied. This study aims at better understanding and treating gynaecological pain. The focus of the study will be provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital, Royal-Victoria Hospital, CHUM St-Luc).

NCT ID: NCT01304589 Completed - Vulvodynia Clinical Trials

Savella in Treatment for Provoked Vestibulodynia

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The investigators will also determine whether associated symptoms in PVD, including psychological distress, impairment of sexual function, physical function, and quality of life, are correlated with a reduction in vulvar pain.

NCT ID: NCT01301001 Completed - Vulvodynia Clinical Trials

A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

Start date: August 2012
Phase: N/A
Study type: Interventional

The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.

NCT ID: NCT01295268 Terminated - Vulvodynia Clinical Trials

Study of Emu Oil vs. Placebo for Vulvar Pain in Women.

Start date: February 2011
Phase: N/A
Study type: Interventional

The goal of this study is to determine if vulvar (external female genitalia) pain is decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement devices, examinations, and questionnaires. Topical emu oil has not been scientifically studied for this condition yet, but related reports show no significant side effects or potential benefits. A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.

NCT ID: NCT01149031 Terminated - Clinical trials for Provoked Vestibulodynia

Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia

LLLT
Start date: June 2010
Phase: N/A
Study type: Interventional

Provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule in response to contact or pressure. In addition, many patients also have pain in response to non-sexual activities such as tampon insertion, gynecological examinations or physical pursuits such as bicycle riding; the severity of other vulvo-vaginal symptoms such as itching, burning and irritation varies. Once women with provoked vestibulodynia develop the syndrome, symptoms may last for months or years; as a result, provoked vestibulodynia has a profound effect on women's sexuality and psychological well-being. The diagnosis of provoked vestibulodynia is usually made by ascertaining if the patient fulfills modified Friedrich's criteria, consisting of 1) a history of vulvar pain, dyspareunia or pain with tampon insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator and 3) no identifiable cause for the pain. The etiology of this condition remains unknown. Proposed causes include chronic inflammation, peripheral neuropathy, genetic, immunologic and hormonal factors, infectious, psychological disorders, sexual dysfunction or disturbance in the central nervous system. Because the cause of provoked vestibulodynia remains unknown, many different treatments have been described for this condition, including topical and intra-lesional corticosteroids, topical anesthetics such as lidocaine, topical estrogen, topical or oral antidepressants or anti-convulsants, biofeedback or physical therapy, surgical resection of the involved tissue (vestibulectomy) and a variety of complementary and alternative therapies. Low level laser therapy (LLLT) is an emerging medical technique in which exposure to low-level laser light or light emitting diodes might stimulate or inhibit cellular function, possibly leading to beneficial clinical effects. Clinical applications that show some potential of effectiveness include treating soft tissue injury, chronic pain, and wound healing. The usage of low level laser therapy was found effective in various pain syndromes, and has no side effects. Since inflammatory mechanisms have been proposed in the pathogenesis of provoked vestibulodynia, and as there is no effective therapy for this syndrome, the investigators intend to study whether low level laser therapy might be an effective therapy for provoked vestibulodynia.

NCT ID: NCT01048177 Withdrawn - Vulvodynia Clinical Trials

A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia

VV/IC
Start date: December 2012
Phase: Phase 2
Study type: Interventional

In order to investigate whether the pain in women with vulvodynia may represent bladder origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women with generalized vulvodynia. Those women with a positive test for IC, we will be performing a series of bladder treatments (instillations) for IC and checking symptoms throughout the trial to see if significant relief of vulvar pain can be obtained through treatment for IC.

NCT ID: NCT00874484 Completed - Vulvodynia Clinical Trials

Enoxaparin as Treatment for Vulvodynia

Start date: March 2009
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that injections of Low molecular weight heparin (LMWH) [enoxaparin] will reduce pain in women with vulvodynia.

NCT ID: NCT00873301 Completed - Vulvodynia Clinical Trials

The Effectiveness of Vestibulectomy

Start date: January 2009
Phase: N/A
Study type: Interventional

Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination before and 6 months after vestibulectomy. The investigators hypothesize that pain will decrease.

NCT ID: NCT00853229 Terminated - Vulvodynia Clinical Trials

Pregabalin for the Treatment of Vulvodynia

Start date: February 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

NCT ID: NCT00814632 Completed - Vulvodynia Clinical Trials

CC-10004 For The Treatment Of Vulvodynia

Start date: December 2008
Phase: Phase 2
Study type: Interventional

Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual disorders. Women are generally treated with medications such as anti-histamines, anti-depressants and anti-inflammatories, or with physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is utilized as a last resort.