Active clinical trials for "Vulvar Vestibulitis"

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.

Provoked vestibulodynia (PVD) is one major subtype of vulvar pain, affecting close to one in ten women and resulting in pain during attempts at vaginal intercourse and/or attempts to insert a digit, device or tampon into the vagina. Management involves a multidisciplinary approach, through physicians, psychologists, sex therapists and physiotherapists. Low Level Laser Therapy (LLLT) is a therapeutic modality involving irradiation of injured or diseased tissue with a combination of red and infrared light. This process is thought to initiate a series of physiological reactions within the cells exposed to light at these wavelengths, leading to the restoration of normal cell structure and function. The investigators hypothesize that LLLT will be effective at reducing pain and improving sexual function among women with PVD. The purpose of this double-blind randomized controlled trial is to assess the feasibility of using a LLLT intervention for the management of PVD in women. The aim is to determine whether there is evidence of a positive effect of LLLT, delivered using a BioFlexTM laser system (Health Canada Licence No. 7931) and a semi-standardized protocol, in terms of self-reported pain and sexual functioning, physiological responses to pressure applied at the vulvar vestibule, tonic and phasic activation of the PFM and/or corticomotor excitability to the PFMs in women with PVD with or without concurrent vaginismus (VAG) when compared to an identical treatment schedule where sham LLLT is delivered. Women will be recruited from among eighty women with confirmed PVD and PVD+VAG who participate in a cross sectional study investigating pelvic floor muscle involvement in PVD. If they are interested in participating in this intervention study, they will be asked to consent to having their data from the cross sectional study used for the purposes of this concurrent study. Women will be evaluated before the intervention using a battery of physical assessments and questionnaires, re-evaluated on primary outcome measures 3 weeks after initiating the intervention and then re-evaluated using the complete battery of physical assessment and questionnaires at the end of the intervention period. If we secure further funding, a medium term (12 weeks later) follow-up will be added. Physical assessment will include evaluation of pressure-pain threshold, temporal summation of pain, electromyographic (EMG) evaluation of PFM activity, responses of the PFMs to pressure applied at the vulvar vestibule using a custom electronic vulvalgesiometer, motor evoked potential threshold, amplitude, latency and the duration of cortically mediated silent period recorded from the PFMs following transcranial magnetic stimulation. The questionnaires will include the The Vulvar Pain Assessment Questionnaire (VPAQ), the Female Sexual Functioning Index, the Pain Catastrophizing Scale, the Depression Anxiety Stress Scales and the Central Sensitization Inventory. Three weeks and 12 weeks after the first start of treatment, the Global Perception of Improvement and Global patient satisfaction with treatment questionnaires will be administered. These will be repeated 12 weeks after completing treatment if funding becomes available.

Women with provoked vestibulodynia (PVD) suffer from severe dyspareunia 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.

The purpose of the study was to compare the effectiveness of cognitive behavioural therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia (PVD).

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.

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.

This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.

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).

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

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.