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Vulvodynia clinical trials

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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: NCT01747161 Completed - Clinical trials for Localized Provoked Vulvodynia

Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia

VVS-01
Start date: December 17, 2013
Phase: Phase 2
Study type: Interventional

In this study we will investigate the efficacy and safety of infiltration of the vestibulum vaginae with botulin toxin in women who were diagnosed with localized provoked vulvodynia. In literature covering this subject we find that the prevalence of this condition is between 10 and 15%. Especially young, sexually active women suffer from this problem and some of them are not capable of having sexual relations with their partner because of this burning pain. The most probable explanation for the physiopathological mechanism is an increase of nerve endings in the epithelium of the vestibulum, with an increase and activation of pain receptors in the vestibular mucosa. It also seems that patients with vestibulodynia have a higher tonus of the pelvic floor muscles, a greater muscle contraction in response to pain and a lower capacity of relaxation. Botulin toxin (Botox) is a neurotoxin that causes a temporary paralysis of the muscle cells. That way it can decrease the increased tension of the pelvic floor muscles Botox also inhibits the pain receptors in the vestibulum. Patients will be recruited through the gynecology consultations. Every patient with localized provoked vulvodynia that has tried previous treatments (pelvic floor muscle therapy, antidepressants, anti-epileptics, local anesthetics) will undergo Q-tip testing. If positive and there are no underlying diseases, the patient will be invited to participate in the study and after oral and written informed consent, will be included in the study population. Every 6 weeks there will be given injections with 50 units of botulin toxin, on 6 different spots in the vestibulum. 50 % of the subjects will receive physiological water instead of Botox (control population). After 3 sessions, we will assess if there is any difference in provoked pain in treated patients vs. placebos through Q-tip testing.

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.

NCT ID: NCT01704443 Completed - Clinical trials for Provoked Vestibulodynia

Integrated Mindfulness for Provoked Vestibulodynia

IMPROVED
Start date: April 2008
Phase: N/A
Study type: Interventional

This study aims to test the efficacy of a 4-session intervention (Group psychoeducational treatment) using a randomized study design. Participants will be randomized in to 'immediate treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session IMPROVED treatment, just as women randomized to the experimental group, after the end of their wait-list period.

NCT ID: NCT01664962 Completed - Vulvodynia Clinical Trials

Search for Genetic Basis of Vulvodynia

Start date: November 2008
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

NCT ID: NCT01628679 Completed - Vulvodynia Clinical Trials

Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

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

Hypothesis: 1. 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. 2. 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.

NCT ID: NCT01582373 Completed - Vestibulodynia Clinical Trials

Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia

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

The current pilot study aims to assess the feasibility and preliminary efficacy of a novel, 12-week targeted couple intervention (CBCT) for women with vulvodynia and their partners.

NCT ID: NCT01539317 Completed - Breast Cancer Clinical Trials

Therapy to Prevent Sexual Pain in Breast Cancer Survivors

Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.