预约演示

更新于：2025-05-07

Vulvar Vestibulitis

外阴前庭炎

更新于：2025-05-07

基本信息

别名

Vestibulitides, Vulvar、Vestibulitis, Vulvar、Vestibulodynia

+ [16]

简介

Inflammation of the vulvar vestibular region at the entrance of the VAGINA, generally involving surface mucosa and submucosal vestibular glands. It is characterized by ERYTHEMA and chronic recurrent pain in this area.

关联

项与外阴前庭炎相关的药物

Milnacipran Hydrochloride

盐酸米那普仑

靶点

NET x SERT

作用机制

NET抑制剂 [+1]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期1999-09-22

项与外阴前庭炎相关的临床试验

NCT06660212

/ RecruitingN/AIIT

Is Multimodal Physiotherapy And/or Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia: a Randomized Controlled Trial

This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and sexual health of an astounding one in five Canadian women, yet access to evidence-informed management approaches is limited. We will employ four intervention groups: PBM, sham PBM (control), PBM combined with mPT, and mPT with sham PBM to evaluate the effectiveness of each approach on its own and the two approaches in combination.
Among those who experience PVD, we seek to answer:
1. Relative to baseline and to sham PBM, does a 14-week intervention involving PBM, mPT, or a combination of mPT and PMB reduce vulvar pain severity reported on the Vulvar Pain Assessment Questionnaire (VPAQ)?
2. Is a combined mPT and PBM intervention more effective than mPT or PMB alone when considering vulvar pain severity and/or related domains as measured through VPAQ?
3. Are positive changes in vulvar pain severity and related domains observed following a 14-week intervention involving PBM, mPT or a combination of PBM and mPT retained at 6 months and at 1 year?
Secondary objectives include determining the effectiveness of PBM, mPT, and mPT combined with PBM relative to sham PBM on: Patient Global Impression of Change (PGIC), pain sensitivity measured using provocative tests, the other domains of the VPAQ, sexual function, as well as investigating mediating effects of psychosocial variables (central sensitization index, chronic pain acceptance), gender identity, and the presence of vaginismus on patient response to mPT, PBM and mPT combined with PBM. Lastly we will monitor patient satisfaction with the interventions, adherence to the interventions, and any adverse events.

开始日期2025-03-17

申办/合作机构

University of Ottawa

[+1]

NCT06840314

/ RecruitingN/AIIT

VIBRENT- VIBRating Vs Traditional Therapy for Treatment of ENTry Dyspareunia

The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators.
The main questions it aims to answer are:
1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators
2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators?
Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief.
Participants will:
* Be randomly assigned to use either the Kiwi device or traditional vaginal dilators.
* Use the assigned device three times per week for 15 minutes per session over four weeks.
* Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.

开始日期2025-03-01

申办/合作机构

MedStar Research Institute

ChiCTR2500097442

/ SuspendedN/AIIT

A randomized controlled trial of platelet-rich plasma therapy for female vaginal laxity

开始日期2025-02-20

申办/合作机构-

100 项与外阴前庭炎相关的临床结果

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100 项与外阴前庭炎相关的转化医学

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0 项与外阴前庭炎相关的专利（医药）

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649

项与外阴前庭炎相关的文献（医药）

2025-10-01·Neural Regeneration Research

Lighting the shades of hidden pain: a role for spinal cord neurons and microglia in vestibulodynia

Article

作者: Morace, Andrea Maria ; Gargano, Francesca ; Guida, Francesca ; Infantino, Rosmara ; Belardo, Carmela ; Luongo, Livio ; Boccella, Serena ; Maione, Sabatino

2025-04-15·The Journal of Sexual Medicine

Photobiomodulation therapy for the treatment of vulvar pain among those with provoked vestibulodynia: a randomized controlled trial

Article

作者: Pukall, Caroline ; I Antonio, Flavia ; McLean, Linda

AbstractBackgroundProvoked vestibulodynia (PVD) is characterized by recurring pain confined to the vulvar vestibule; histological studies show inflammatory mediators and neural proliferation in the vulvar tissues.ObjectiveTo determine whether a 15-session photobiomodulation (PBM) intervention is more effective than sham-PBM for reducing vulvar pain. Secondary objectives were to evaluate the effect of the PBM intervention on broader domains of vulvar pain, psychological outcomes, sexual function, perceived improvement and satisfaction, as well as to describe adverse events and adherence.DesignRandomized controlled trial.ParticipantsParticipants with PVD were recruited from the local community.AllocationRandomized allocation to real- or sham-PBM (1:1) was concealed from participants and all members of the research team until after data analysis was complete.OutcomesPrimary outcomes: pressure pain threshold (PPT), pain reported on the tampon test, and vulvar pain sensitivity reported on the Vulvar Pain Assessment Questionnaire (VPAQ). Secondary outcomes: pain-related domains reported on the VPAQ, sexual function, depression, anxiety and stress, pain catastrophizing, central sensitization to pain, Patient Global Perception of Improvement (PGPI), Perceived overall percent improvement (P%I), perceived satisfaction with treatment (%), adherence and adverse events. The primary end point was one week following the last PBM intervention session.InterventionFifteen sessions of a real- or sham-PBM intervention were delivered over an 8-week period, progressing through five stages of incremental exposure to light in the red and near-infrared spectra applied to the vulvar vestibule, the perineum, and the sacral region.ResultsThirty participants (16 real-PBM, 14 sham-PBM) enrolled and received their intended intervention; one (sham-PBM) was lost to follow-up. Vulvar pain was reduced more in the real- compared to the sham-PBM group; between group differences were 28.2-112.0 g/cm2 (d = 0.61) for PPT, 0.1-2.5 1(d = 0.60) for pain reported on the tampon test, and 0.1-0.9 (d = 0.87) for pain sensations reported on the VPAQ. Changes in other pain-related domains reported on the VPAQ, psychological outcomes and sexual function were not different between the real- and sham-PBM groups. Adherence to the intervention was nearly 100% among those who completed the study. Most participants in both groups were satisfied or very satisfied with the intervention (real-PBM = 80%; sham-PBM = 64%), with no group differences in satisfaction or perception of improvement.ConclusionsThe PBM intervention resulted in greater reductions in vulvar pain than the sham intervention. However, patients did not perceive that the real-PBM was significantly better than the sham-PBM intervention, and the intervention did not impact psychological outcomes or sexual function.ClinicalTrials.gov Identifier: NCT04234542.

2025-04-15·The Journal of Sexual Medicine

Phase 2 randomized study of abobotulinumtoxinA in patients with provoked vestibulodynia: dose-finding results

Article

作者: Goldstein, Andrew ; Silva, Robert ; Goldstein, Irwin ; Faught, Brooke M ; Dahir, Melissa ; Rubin, Rachel ; Krapf, Jill ; Volteau, Magali ; Bohm-Starke, Nina ; Caetano, Peter

AbstractBackgroundHypertonicity of the pelvic floor muscles is commonly associated with provoked vestibulodynia (PVD); therefore, patients may benefit from treatments that relax the pelvic floor.AimTo define optimal (safe and efficacious) doses of abobotulinumtoxinA (aboBoNT-A) for the treatment of PVD associated with hypertonic pelvic floor muscle dysfunction and to explore use of a novel endpoint for pain assessment for PVD.MethodsThis phase 2, randomized, placebo-controlled study comprised two steps: dose escalation (Stage 1) and dose expansion (Stage 2). Stage 1 included up to four treatment cycles; Cycle 1 was double blind, Cycles 2–4 open label. Patients were assessed for retreatment every 6 weeks. Stage 2 was not conducted because of early study termination by the sponsor, unrelated to observed safety signals. Enrolled patients—premenopausal women with PVD with associated pelvic-floor hypertonia—were randomized (n = 60) 4:1 to receive aboBoNT-A (doses: 100, 300, 400, or 500 units [U]) or placebo.OutcomesThe primary endpoint was safety. Additionally, a novel composite endpoint, dilator maximum tested size was evaluated. This endpoint combined assessment of vaginal-dilator tolerability with patient-reported pain assessment on an 11-point numeric rating scale, used as a surrogate measure of sexual activity in this study.ResultsAll treatment-emergent adverse events (AEs) were mild or moderate in intensity, with no serious AEs or AEs leading to withdrawal reported in the double-blind period. AEs of special interest (urinary incontinence, anal sphincter atonia) were observed at low incidence and predominantly with higher aboBoNT-A doses. The dilator test composite score might be a useful endpoint for pain assessment, with a greater reduction in pain score noted for the 300 U dose group compared with other dose groups and placebo.Clinical implicationsaboBoNT-A was well tolerated in patients with PVD and a novel method for assessing dilator-induced pain was introduced.Strengths and limitationsThe study provided valuable data on use of aboBoNT-A in women with primary or secondary PVD and introduced a novel composite endpoint for assessing dilator-induced pain. Study limitations included the small sample size, limiting formal statistical analysis.ConclusionaboBoNT-A was well tolerated in patients with PVD with no safety signals reported. Further studies are warranted to demonstrate clinically meaningful benefits with repeated treatment.Clinical trial registration numberNCT03598777.

项与外阴前庭炎相关的新闻（医药）

2023-01-01

·templerx.com

Vulva Vestibulitis

Vulva vestibulitis or localized provoked vulvodynia (LPV) is when there is pain in your vestibule, the portion of the vulva surrounding the opening of the vagina. Characterized by a stinging or burning-like pain at the vaginal opening, it’s typically provoked by sexual intercourse and the insertion of objects such as a tampon or speculum into the vagina. Sometimes it can be present during daily activities. Vulva vestibulitis can cause redness and irritation of the skin as well as pain in the glands inside the skin. Classified as a “neuro-inflammatory” condition, vulva vestibulitis involves inflammation which causes pain as the nerves that are involved in sensing pain releases chemicals that promote inflammation, thus causing further pain. Careful examination can reveal redness and unusual sensitivity of the tissue of the vulva. Vulva vestibulitis usually develops between the ages of 20 and 50, and although it is not caused by any single factor, it can often appear after an infection of the lower genital tract, become aggravated by acidic foods, or low levels of estrogen. Symptoms vary in everyone and can be mild or serious to impact your daily life and sexual life. Symptoms may or may not be constant and include: Pain from pressure like sitting, working out, tight clothes, or touch Pain from sex Pain from using a tampon A burning sensation in the vulva Stinging sensation in the vulva Feeling raw Urinating frequently or a sudden feeling like you have to urinate Unusual or irritating vaginal discharge Small red spots around the vestibular glands Current treatments include: Q-tip test: To test for similar pain that a woman could be experiencing, a cotton bud or swab can be pressed onto the vestibular skin to provide a painful sensation. A combination of estradiol, an estrogen hormone, and lidocaine, a local anesthetic, is compounded and applied. Anti-neuropathic analgesics and steroid infiltration into the opening of the vagina may be offered. Pelvic floor therapy: pelvic floor muscles supports the bladder, uterus, and bowel. Pelvic floor therapy aids in strengthen the pelvic muscles. Fenton’s vestibulectomy: the removal of the vestibule or the back wall of the vagina’s tissue. The posterior vaginal wall is then advanced downwards and sutured into position. If you think you may suffer from Vulva Vestibulitis, consult with your OB/GYN.

临床研究