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Subtypes of Provoked Vestibulodynia

NCT02712814 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2022-04-08

No results posted yet for this study

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

Interventions

DRUG

Topical hormonal cream (estrogen)

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

PROCEDURE

Pelvic floor physical therapy

PF physical therapy once weekly for 3 months

PROCEDURE

Low Level Laser therapy

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

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-06-30
Completion
2021-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712814 on ClinicalTrials.gov