Active clinical trials for "Vulvar Vestibulitis"

OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.

Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life, and consequently negatively affects quality of life. Low intensity shock wave therapy produces physical forces that lead to pain relief. Aim: To evaluate the feasibility, safety and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia. Methods: A double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJ/〖mm〗^2 ) using the "Medispec ED-1000®" shock wave generator or sham.

Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high prevalence and important sexual, conjugal and psychological deleterious repercussions, effective evidence-based interventions remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Transcranial direct-current stimulation (tDCS) was shown to be effective in various chronic pain conditions. So far, only one case report study has shown significant pain reduction in women with vulvodynia. The main goal of this randomized controlled trial is to evaluate the efficacy of tDCS in women with PVD compared to sham tDCS. Forty women diagnosed with PVD, by a gynecologist following a standardized protocol will be randomized to either active or sham tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period. Outcome measures will be collected at baseline, after treatment and at 3-month follow-up. The primary outcome is pain during intercourse assessed with a numerical rating scale (NRS). Secondary measurements focus on sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction and Patient Global Impression of Change (PGIC). The investigators expect that active tDCS treatment will significantly reduce pain during intercourse (post-treatment and 3-month follow-up compared to pre-treatment assessment). This trial will provide important information for determining the efficacy of a novel and promising intervention for women with PVD.

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.

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

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.

To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).

Women with provoked vestibulodynia (PVD) suffer from severe dyspareuni and often present a hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale for the study is that for women with PVD who don't succeed to restore the function of the PFM by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the high muscle tonus and thus possibly reduce the coital pain. Objectives and outcome Women with PVD will be recruited for a double blind RCT of 2 injection of 50 Allergan-units BTA (3 months apart) or placebo in the bulbocavernous muscles (situated adjacent to the lower part of the vagina). Primary outcome: The reduction of patient self-reported dyspareunia measured by VAS 0 (no pain) to 100 (worst pain imaginable). Secondary outcome: Pain at tampon insertion measured by VAS 0-100, functional measurement of dyspareunia (see below), the reduction of pelvic floor hyperactivity/tonus, measured with a vaginal manometer, safety aspects and effect duration of BTA, influence on quality of life and psychosexual evaluation.

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.

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.