Subtypes of Provoked Vestibulodynia

NCT02712814 | Completed

• 1 other identifier: 0152-15-COM1
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Provoked Localized Vulvodynia

Outcome Measures

Primary Outcomes (1)

• Change of measure of Q tip test assesing 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 6 months, 9 months and 12 months

Secondary Outcomes (6)

• 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

Study Arms (6)

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)

Drug: Topical hormonal cream (estrogen)

Congenital Neuroproliferative PVD

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

Procedure: Low Level Laser therapy

Acquired neuroproliferative PVD

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

Procedure: Low Level Laser therapy

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

Procedure: Pelvic floor physical therapy

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

Procedure: Pelvic floor physical therapy; Procedure: Low Level Laser therapy

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

Drug: Topical hormonal cream (estrogen); Procedure: Pelvic floor physical therapy

Interventions

Topical hormonal cream (estrogen) DRUG

Patients will be instructed to stop hormonal contraception and to apply 0.1 ml topical cream containing 0.1% of estriol to the vestibule, once daily for 3 months

Hormonally +Hypertonic; Hormonally mediated PVD

Pelvic floor physical therapy PROCEDURE

PF physical therapy once weekly for 3 months

Hormonally +Hypertonic; Hypertonic pelvic muscle dysfunction; Neuroproliferative +Hypertonic

Low Level Laser therapy PROCEDURE

non-thermal laser irradiation (low levels of red and near infrared light) is applied directly to the vestibule

Acquired neuroproliferative PVD; Congenital Neuroproliferative PVD; Neuroproliferative +Hypertonic

Eligibility Criteria

• Age: 18 Years - 40 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
• unprovoked or mixed vulvodynia.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Ramat Eshkol Women health center, Clalit health Services

Jerusalem, Israel

Location

MeSH Terms

Interventions

Estrogens; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 18, 2016
• Study Start: November 30, 2016
• Primary Completion: June 30, 2019
• Study Completion: August 1, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)