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Vulvar Vestibulitis clinical trials

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NCT ID: NCT02393911 Not yet recruiting - Vulvodynia Clinical Trials

Dysbiosis in Localized Provoked Vulvodynia (LPV)

DMLPV
Start date: March 2015
Phase: Phase 3
Study type: Interventional

Currently, the pathogenesis of Localized Provoked Vulvodynia (LPV) has not been elucidated. Few observations may point to involvement of the microbiome: the association of LPV with preceding chronic recurrent candidiasis, and the reports of the beneficial effect of a diet avoiding oxalate on Vulvodynia. Studies in the new field of microbiome research focus on the composition of overall microorganisms in our body and their impacts on our health. Changes in the composition of the vaginal microbiota (dysbiosis) have been linked with different health and disease states. We have also shown recently that women can be divided into 2 groups according to the composition of their vaginal microbiome. The proposed study will compare the vaginal microbiome of women with severe LPV, not treated by diet and otherwise healthy, to women without LPV (we will also compare our results to the NIH HMP data). Vaginal pH and date of menstrual cycle will be checked. We propose that dysbiosis in the vaginal microbiota may trigger the development of LPV.

NCT ID: NCT02362763 Completed - Vestibulodynia Clinical Trials

The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Start date: June 2006
Phase: N/A
Study type: Interventional

Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.

NCT ID: NCT02204319 Completed - Vestibulodynia Clinical Trials

Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief

Start date: March 2014
Phase: N/A
Study type: Interventional

The objectives of this pilot study are to demonstrate effectiveness of application of the Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk low level laser red diode light therapy device, in providing relief of pain symptoms in patients with provoked and non- provoked vulvar vestibulitis; to reduce the frequency of use of oral medications to manage pain symptoms; and to reduce the debilitating affect vulvar vestibulitis has on the patient's daily activities, relationships and emotional well-being.

NCT ID: NCT02197429 Completed - Pain Clinical Trials

Acupuncture for the Treatment of Vulvodynia

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

A randomized controlled pilot study was conducted to evaluate the effect of an acupuncture protocol for the treatment of vulvodynia. Hypotheses: 1. Acupuncture reduces vulvar pain and dyspareunia in women with vulvodynia. 2. Acupuncture increases sexual function in women with vulvodynia.

NCT ID: NCT01996384 Completed - Vulvodynia Clinical Trials

Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

Start date: November 2013
Phase: Phase 1
Study type: Interventional

The investigators research project is a randomized, controlled, single-blinded, feasibility pilot study. The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment commonly used for other pain disorders. The investigators will compare two types of acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.

NCT ID: NCT01935063 Completed - Dyspareunia Clinical Trials

Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia

CBCT-RCT
Start date: March 6, 2014
Phase: N/A
Study type: Interventional

Chronic pain problems involving the female reproductive system are major health concerns for all women. Poorly understood, they entail great personal and financial cost. One such condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%. Despite its negative impact on psychosexual and relationship satisfaction, there is little research examining empirically-tested treatments for afflicted couples. The proposed research builds on findings from our work focusing on the impact of relational factors on vulvodynia, and our previous research evaluating the efficacy of group cognitive-behavioral therapy for this problem. This two-centre randomized clinical trial aims to assess the efficacy of a novel, 12-week targeted couple therapy (CBCT) for women with vulvodynia in comparison to one of the most commonly prescribed first line medical interventions, topical lidocaine. Primary research question: Is there a significant difference between the two treatments on women's pain during intercourse post-treatment? Secondary research questions will assess for significant differences between the two treatments post-treatment and at 6-month follow-up on multidimensional aspects of pain using the McGill Pain Questionnaire, women and partners' sexuality (sexual function and satisfaction), psychological adjustment (anxiety, depression, catastrophizing, self-efficacy, attributions, and quality of life), relationship factors (partner responses, couple satisfaction, attachment, and communication styles), and self-reported improvement and treatment satisfaction. Results of this study will improve the health and quality of life of patients with vulvodynia by rigorously testing the efficacy of a novel couples treatment.

NCT ID: NCT01753258 Completed - Pregnancy Clinical Trials

Outcomes of Delivery in Patients With Dyspareunia

Start date: January 2013
Phase: N/A
Study type: Observational

The focus of this pilot study is to determine if a woman who experiences pain during sexual intercourse has a higher risk of complications during labor and delivery secondary to pelvic floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is unclear whether women with prepartum dyspareunia experience an improvement following vaginal delivery. While physicians may expect that vaginal birth improves dyspareunia due to the stretching effect on pelvic floor, to date, there is insufficient evidence to support this claim. The Investigators plan to prospectively study 200 patients at our Institution, collect information regarding birth and follow them, via questionnaires, regarding their dyspareunia postpartum.

NCT ID: NCT01741948 Withdrawn - Vestibulodynia Clinical Trials

Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia

Start date: January 2012
Phase: N/A
Study type: Observational

There have been reports in the medical literature demonstrating a link between the development of provoked vestibulodynia (PVD), a sexual pain disorder, and hormonal contraceptive (HC) use. The purpose of this pilot study is to assess the prevalence of HCs induced PVD among a HC naïve population, to evaluate which of the components of the HCs are associated with a higher risk of the development of PVD, and to evaluate which clinical and genetic factors predispose the patient to HCs induced PVD. Assessments will be made through patient questionnaires, physical examinations, and blood tests. Microarray techniques will be employed to characterize, on a global level, the gene expression profiles of women who develop PVD in comparison to those who do not develop PVD. Patients will be followed for a year. Results will be used to develop a larger clinical trial.

NCT ID: NCT01731288 Completed - Vulvodynia Clinical Trials

Pregnancy, Childbirth Intentions and Outcomes Under Sexual Pain

PRECIOUS
Start date: March 2012
Phase: N/A
Study type: Observational

The main purpose of this study is to assess conception, pregnancy, childbirth, and pain experiences among women who have been diagnosed with vulvodynia. Specifically, this study aims to examine the following among women who have been diagnosed with vulvodynia: 1) rates of pregnancy/childbirth and desire for children; 2) fear of pregnancy and childbirth; 3) potential difficulties experienced while attempting to become pregnant and during pregnancy/childbirth; 4) methods used to become pregnant and deliver; 5) methods used to manage vulvodynia symptoms during pregnancy; and 6) pain outcomes associated with pregnancy. Very little research has examined pregnancy/childbirth experiences among women with vulvodynia, or the natural history of vulvodynia. As such this is a preliminary investigation that will provide descriptive information regarding many of the proposed research questions. Based on the clinical experience of the investigators, it is expected that women with vulvodynia will report lower rates of pregnancy and higher levels of fear about pregnancy and childbirth in comparison to women without such pain. It is also expected that women with vulvodynia will report more difficulties becoming pregnant as compared to women without such pain, and that women with vulvodynia will report more elective nonvaginal births in comparison to vaginal births.

NCT ID: NCT01704456 Completed - Clinical trials for Provoked Vestibulodynia

Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia

COMFORT
Start date: October 2012
Phase: N/A
Study type: Interventional

This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart. The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is no worse than an 8-session CBT intervention for decreasing women's pain intensity, sexual distress, catastrophizing and hypervigilance towards pain.