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The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia

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ClinicalTrials.gov Identifier: NCT02892214
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Meir Medical Center

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.

Condition or disease Intervention/treatment
Localized Provoked Vulvodynia Procedure: Pelvic floor physical therapy Drug: estriol cream (ovestin) Procedure: Low-level-laser therapy

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia, and the Mental Health of the Patient
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hypertonic pelvic muscle dysfunction
In this subgroup, pelvic floor (PF) muscles become tight and tender. Typically, the pain is much worse at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule.
Procedure: Pelvic floor physical therapy
Hormonally mediated PVD
The pain began while taking hormonal contraceptive or other medications that affect hormones, after removal of ovaries, breastfeeding or menopause. The entire vestibule is tender and vestibular mucosa is often dry and thin.
Drug: estriol cream (ovestin)
Neuroproliferative PVD
In this condition, we speculate that women have an increased number of nociceptors in the vestibular mucosa. Pain is primary and there is tenderness of the entire vestibule.
Procedure: Low-level-laser therapy



Primary Outcome Measures :
  1. Change of measure of Q tip test assessing pain intensity [ Time Frame: Change in measure between recruitment to 3 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.


Secondary Outcome Measures :
  1. Measurement of vestibular tenderness using a vulvar algesiometer [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]
  2. Change of pain using Visual analog scale [ Time Frame: Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months ]
  3. Adherence to therapy [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]
    Adherence to therapy will be assessed by calculating attendance to planed appointments (physical therapy, medical appointments and LLL treatments)

  4. Female sexual function index questionnaire [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]
  5. Pelvic floor hypertonicity measurements [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]
    Pelvic floor muscle tonicity will be evaluated using manual palpation of the muscles by the physician.

  6. Brief Symptom Inventory-18 questionnaire (evaluating emotional symptoms) [ Time Frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892214


Contacts
Contact: Ahinoam Lev Sagie, MD +972-54-4327178 levsagie@netvision.net.il

Locations
Israel
Merkaz Briot Haisha, Ramat Eshkol Recruiting
Jerusalem, Israel
Contact: Ahinoam Lev-Sagie, MD         
Sponsors and Collaborators
Meir Medical Center

Publications:
Antonovsky, A. (1987). How people manage stress and stay well. San Francisco, CA, US: Jossey-Bass Unraveling the mystery of health.
Brennan, K.A., Clark, C.L., & Shaver P.R. (1998). Self-report measurement of adult attachment: An integrative overview. In J.A. Simpson & W.S. Rholes (Eds.), Attachment theory and close relationships, (pp. 46-76). NY,US: Guilford Press.
Buunk, B. P., Berkhuysen, M. A., Sanderman, R., Nieuwland, W., & Ranchor, A. V. (1996). Active engagement, protective buffering and overprotection: Instruments to measure the role of the spouse in heart rehabilitation. Gedrag & Gezondheid, 24, 304- 113.
Cohen, S., & Spacapan, S. (1978). The aftereffects of stress: An attentional interpretation. Environmental Psychology and Nonverbal Behavior, 3(1), 43-57.
Sullivan, M. J. L., Bishop, S., & Pivic, J. (1995). The pain catastrophizing scale: Development and validation. Psychological Assessment, 7, 524-532.

Responsible Party: Ahinoam Lev-Sagie, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02892214     History of Changes
Other Study ID Numbers: 0089-16-COM1
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis