The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia

NCT02892214 | Completed DMC

• 1 other identifier: 0089-16-COM1
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Provoked Vulvodynia

Outcome Measures

Primary Outcomes (1)

• Change of measure of Q tip test assessing pain intensity

  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.

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

Secondary Outcomes (6)

• Measurement of vestibular tenderness using a vulvar algesiometer

  Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.

• Change of pain using Visual analog scale

  Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months

• Adherence to therapy

  Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.

• Female sexual function index questionnaire

  Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.

• Pelvic floor hypertonicity measurements

  Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.

Study Arms (3)

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

Interventions

Pelvic floor physical therapy PROCEDURE

Hypertonic pelvic muscle dysfunction

estriol cream (ovestin) DRUG

Hormonally mediated PVD

Low-level-laser therapy PROCEDURE

Neuroproliferative PVD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Merkaz Briot Haisha, Ramat Eshkol

Jerusalem, Israel

Location

Related Publications (11)

• Andrews JC. Vulvodynia interventions--systematic review and evidence grading. Obstet Gynecol Surv. 2011 May;66(5):299-315. doi: 10.1097/OGX.0b013e3182277fb7.

  PMID: 21794194 BACKGROUND

• Antonovsky, A. (1987). How people manage stress and stay well. San Francisco, CA, US: Jossey-Bass Unraveling the mystery of health.

  BACKGROUND

• Bergeron S, Binik YM, Khalife S, Pagidas K, Glazer HI, Meana M, Amsel R. A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001 Apr;91(3):297-306. doi: 10.1016/S0304-3959(00)00449-8.

  PMID: 11275387 BACKGROUND

• Bergeron S, Brown C, Lord MJ, Oala M, Binik YM, Khalife S. Physical therapy for vulvar vestibulitis syndrome: a retrospective study. J Sex Marital Ther. 2002 May-Jun;28(3):183-92. doi: 10.1080/009262302760328226.

  PMID: 11995597 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.

  PMID: 2926629 BACKGROUND

• Cohen, S., & Spacapan, S. (1978). The aftereffects of stress: An attentional interpretation. Environmental Psychology and Nonverbal Behavior, 3(1), 43-57.

  BACKGROUND

• Meredith P, Ownsworth T, Strong J. A review of the evidence linking adult attachment theory and chronic pain: presenting a conceptual model. Clin Psychol Rev. 2008 Mar;28(3):407-29. doi: 10.1016/j.cpr.2007.07.009. Epub 2007 Jul 19.

  PMID: 17719157 BACKGROUND

• Sadownik LA. Clinical profile of vulvodynia patients. A prospective study of 300 patients. J Reprod Med. 2000 Aug;45(8):679-84.

  PMID: 10986689 BACKGROUND

• Sullivan, M. J. L., Bishop, S., & Pivic, J. (1995). The pain catastrophizing scale: Development and validation. Psychological Assessment, 7, 524-532.

  BACKGROUND

MeSH Terms

Interventions

Estriol; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: November 30, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)