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临床试验/NCT02712814
NCT02712814已完成不适用

Subtypes of Provoked Vestibulodynia: A Prospective Study to Evaluate a Diagnostic Algorithm in Regard to Different Treatment Modalities

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2016年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Change of measure of Q tip test assesing pain intensity

研究概览

简要总结

The proposed study will evaluate a clinical algorithm for the diagnosis and treatment of provoked vestibulodynia (PVD). The algorithm, distinguishes between four subtypes of PVD: hormonally mediated PVD, hypertonic pelvic floor dysfunction, congenital neuroproliferative PVD and acquired neuroproliferative PVD, based on a patient's history and physical exam. The study will follow patients diagnosed with PVD, for one year, and evaluate the treatment outcome in the different subgroups. Investigators hope that conducting a prospective study, showing clinical benefit and improved outcome for patients classified according to this method may change the common practice of "trial and error" based treatment, and will improve clinical results.

详细描述

Background Provoked vestibulodynia (PVD) is the term describing a syndrome of provoked, localized allodynia of the vestibule of the vulva, not explained by another condition, and lasting more than 3 months. PVD is not a defined disease but rather a symptom. It is thought that PVD represent a group of distinct disorders that have been classified together because they produce pain in the same anatomic location. Causes of these disorders include hormonal imbalance, mainly caused by hormonal contraception, nerve fiber proliferation in the vestibular mucosa and hypertonic pelvic floor dysfunction. PVD may appear with sexual debut or first attempts to insert a tampon (primary PVD) or can be a new onset of pain with activities that did not previously illicit pain (secondary PVD).

Studies found that different factors such as genetic, inflammatory mediators, recurrent vaginitis, allergy and trauma may be involved in the development of PVD. A high percentage of patients with vulvar pain report an antecedent history of vulvovaginal candida infection, although it is unknown if this represents a true increase in incidence or a misdiagnosis. It has been suggested that repeated vulvovaginal infections are a triggering event for some women leading to chronic vulvar pain. This observation has led to hypothesis that in patients with neurogenic vulnerability, an initiating event or series of events may lead to chronic vulvar pain.

Treatment of vulvodynia is generally predicated on a trial and error basis, because the pathogenesis is not defined. The result is that many forms of therapeutic interventions have been used, yet the evidence remains largely inconclusive, the response rate varies between 40-85%, and many women do not respond to any of the treatments. Unfavorable outcomes to therapy can be explained by grouping patients with different conditions under one diagnosis, and then studying an intervention that might only help one subset of the conditions. This can lead to an apparent lack of effect, due to dilution of the patient subpopulations.

A different approach to diagnosis and treatment of PVD was suggested by Dr. Andrew Goldstein. He classifies PVD into groups, based on history and examination findings:

  1. Hormonally mediated PVD - The pain began while taking hormonal contraceptive or other medications that affect hormones, after removal of ovaries, breastfeeding or menopause. Typically, patients have a low calculated free testosterone and complain of dryness and decreased libido. The entire vestibule is tender and vestibular mucosa is often dry and thin. Treatment includes stopping hormonal contraception and application of topical estradiol with testosterone to the vestibule.
  2. Hypertonic pelvic muscle dysfunction - In this subgroup, pelvic floor (PF) muscles become tight and tender. Patients often have other symptoms suggesting hypertonicity (urinary frequency, urgency and hesitancy, constipation, hemorrhoids and anal fissures), and predisposing factors, such as musculoskeletal disorders or anxiety may coexist. Typically, the pain is much worse at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule. Treatment includes PF physiotherapy, with an optional addition of muscle relaxants (valium suppositories and Botulinum toxin injections).
  3. Neuroproliferative PVD- In this condition, women have an increased number of nociceptors in the vestibular mucosa. This group is further subdivided into congenital and acquired forms. In the congenital subgroup, vestibular pain has always been present, and there may be sensitivity to palpation of the belly button (which is an evidence of a congenital neuronal hyperplasia within the tissue derived from the urogenital sinus). With acquired neuroproliferative PVD, the pain may begin after a severe allergic reaction or vaginitis. There is tenderness of the entire vestibule. Treatments include topical anaesthetics, antidepressants, antiseizure drugs, capsaicin cream and vulvar vestibulectomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • A history of 3 months or more of vulvar pain suggestive of PVD, i.e. symptoms of pain on vaginal penetration (insertional dyspareunia and/or pain with tampon insertion).
  • On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
  • No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.
  • Exclusion criteria:
  • other causes for vulvar pain
  • pregnancy or a planned pregnancy in the upcoming year
  • unprovoked or mixed vulvodynia.

排除标准

  • 未提供

研究组 & 干预措施

Hormonally mediated PVD

  • The entire vestibule is tender
  • The pain began while taking hormonal contraceptive
  • Secondary PVD
  • On exam, atrophic vestibular tissue (dry and thin)

干预措施: Topical hormonal cream (estrogen) (Drug)

Acquired neuroproliferative PVD

  • The entire vestibule is tender
  • Secondary PVD, The pain had begun after a severe allergic reaction or vaginitis.
  • Normal appearing vestibule

干预措施: Low Level Laser therapy (Procedure)

Neuroproliferative +Hypertonic

The entire vestibule is tender, but worse at 4-8 o'clock position of the vestibule

  • Primary PVD
  • There may be sensitivity to palpation of the umbilicus
  • Normal appearing vestibule
  • Pelvic floor muscles are tight and tender

干预措施: Pelvic floor physical therapy (Procedure)

Congenital Neuroproliferative PVD

  • The entire vestibule is tender
  • Primary PVD
  • There may be sensitivity to palpation of the umbilicus
  • Normal appearing vestibule

干预措施: Low Level Laser therapy (Procedure)

Hypertonic pelvic muscle dysfunction

  • The pain is at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule
  • Pelvic floor muscles are tight and tender
  • Primary or Secondary PVD

干预措施: Pelvic floor physical therapy (Procedure)

Neuroproliferative +Hypertonic

The entire vestibule is tender, but worse at 4-8 o'clock position of the vestibule

  • Primary PVD
  • There may be sensitivity to palpation of the umbilicus
  • Normal appearing vestibule
  • Pelvic floor muscles are tight and tender

干预措施: Low Level Laser therapy (Procedure)

Hormonally +Hypertonic

The entire vestibule is tender, but worse at 4-8 o'clock position of the vestibule

  • The pain began while taking hormonal contraceptive
  • Secondary PVD
  • On exam, atrophic vestibular tissue (dry and thin)
  • Pelvic floor muscles are tight and tender

干预措施: Topical hormonal cream (estrogen) (Drug)

Hormonally +Hypertonic

The entire vestibule is tender, but worse at 4-8 o'clock position of the vestibule

  • The pain began while taking hormonal contraceptive
  • Secondary PVD
  • On exam, atrophic vestibular tissue (dry and thin)
  • Pelvic floor muscles are tight and tender

干预措施: Pelvic floor physical therapy (Procedure)

结局指标

主要结局

Change of measure of Q tip test assesing pain intensity

时间窗: Change in measure between recruitment to 3 months, 6 months 6 months, 9 months and 12 months

The exam is performed by touching the vestibule with a cotton-tip applicator in 6 defined points (2,5,6,7, 10 and 12),while the patient is being asked to rate the intensity of pain verbally from 0 to 10 at each point.

次要结局

  • Visual analog scale (VAS)(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months)
  • Measurement of vestibular tenderness using a vulvar algesiometer(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months)
  • QOL parameters (questionnaire)(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months)
  • Improvement in condition using a verbal report(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months)
  • Tampon test(Every month for one year)
  • Female sexual function index(Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahinoam Lev-Sagie

MD

Meir Medical Center

研究点 (1)

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