The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia
Condition: Localized Provoked Vulvodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Observational [Patient Registry]

Summary: 
      The proposed study will evaluate how personality characteristics, cognitive factors and the
      emotional and behavioral responses of patients with provoked vestibulodynia (localized
      provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to
      therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional
      health and sexual functioning.
    

Detailed description: 
      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.

      Studies found that different factors such as genetic, inflammation, recurrent vaginitis,
      allergy, trauma, emotional and neural may be involved in the development of PVD.

      Treatment of PVD 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 rates varies considerably, and
      many women do not respond to any of the treatments. It is therefore important to recognize
      which factors mediate the syndrome's severity, and influence the effectiveness of treatments.

      The proposed study will evaluate how different patients' characteristics (personality,
      cognitive) and responses (emotional and behavioral) influence the natural history of the
      syndrome and the response to treatment. The study is based on the bio-psycho-social model and
      the adult attachment theory, which integrates psychosocial factors to define susceptibility
      to acquire pain disorders and predict response to therapy. According to this model, choosing
      effective coping strategy during a crisis and receiving support from a spouse are vital for
      recovery.

      The study aim to:

        1. Characterize interactions between attachment patterns, personality types, cognitive
           factors (catastrophization, coherence, and partner's support), emotional factors (coping
           strategies, emotional stress and satisfaction from intimate relationship) to pain
           levels, pelvic floor hypertonicity, sexual function and patient's emotional health.

        2. Examine whether treatments' results are influenced by personality, relationship,
           cognitive, emotional and behavioral characteristics of the patient.

        3. Recognize factors that influence the extent of adherence to treatment.

        4. Characterize patients' profile in regard to successful outcome.

      Methods Patients will be recruited from the clinic for vulvovaginal disorders in Clalit
      Healthcare services in Jerusalem. The diagnostic procedures, patients' sub-classification and
      the proposed treatments in the current protocol are identical to those currently used in the
      clinic. Each patient will undergo a standard evaluation which includes: detailed history
      intake, vulvar and vaginal examination, evaluation of vestibular tenderness (Q tip test),
      pelvic floor musculature tenderness examination, vaginal pH measurement, saline and 10%
      potassium hydroxide microscopy, yeast and bacterial cultures and STD screening.

      Patients who fulfill diagnostic criteria of PVD and who will be willing to participate in the
      study will be asked to sign an informed consent and complete the following self-administered
      intake questionnaires:

        -  Socio-demographic questionnaire (age, marital status, religios, PVD onset, health
           status, education etc.)

        -  Close Relations Experiences questionnaire

        -  Five Factor Inventory -NEO-FFI

        -  Pain catastrophizing questionnaire

        -  Sense of Coherence Scale

        -  Ways of giving support questionnaire

        -  COPE -Multidimensional Coping Inventory

        -  Semantic Differential Measure of Marital Satisfaction

        -  PSS-10 - Perceived Stress Scale

        -  FSFI-Female Sexual Function Index

      Instructions for treatment will be given in regards to the diagnosis. Patients will be
      instructed to schedule follow-up appointments at 3,6,9, and 12 months. During follow-up
      appointments they will be assessed in regard to vestibular tenderness (using various
      parameters), as well as by the same questionnaires. Additional treatment will be recommended
      according to medical status, in an identical way to this routinely used in the clinic.
    

Intervention name(s): Pelvic floor physical therapy; estriol cream (ovestin); Low-level-laser therapy
Intervention type(s): Procedure; Drug; Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare
        services in Jerusalem.