Clinical trial NCT02892214: The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia
Official title: The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia, and the Mental Health of the Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Provoked Vulvodynia
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
3. No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.

Exclusion Criteria:

1. other causes for vulvar pain
2. pregnancy or a planned pregnancy in the upcoming year
3. diagnosis of chronic disease that may affect central nervous system or general function.
4. usage of psychiatric medications or those affecting pain modulation.
5. unprovoked or mixed vulvodynia

Primary outcomes:
measure: Change of measure of Q tip test assessing pain intensity
timeFrame: Change in measure between recruitment to 3 months, 6 months , 9 months and 12 months
Secondary outcomes:
measure: Measurement of vestibular tenderness using a vulvar algesiometer
timeFrame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
measure: Change of pain using Visual analog scale
timeFrame: Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months
measure: Adherence to therapy
timeFrame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
measure: Female sexual function index questionnaire
timeFrame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
measure: Pelvic floor hypertonicity measurements
timeFrame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
measure: Brief Symptom Inventory-18 questionnaire (evaluating emotional symptoms)
timeFrame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Merkaz Briot Haisha, Ramat Eshkol
Study officials:
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