Subtypes of Provoked Vestibulodynia: A Prospective Study to Evaluate a Diagnostic Algorithm in Regard to Different Treatment Modalities

NCT02712814 COMPLETED

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.

Details

Lead sponsor	Meir Medical Center
Status	COMPLETED
Enrolment	113
Start date	2016-11-30
Completion	2021-08

Conditions

• Provoked Localized Vulvodynia

Interventions

• Topical hormonal cream (estrogen)
• Pelvic floor physical therapy
• Low Level Laser therapy

Primary outcomes

• Change of measure of Q tip test assesing pain intensity — Change in measure between recruitment to 3 months, 6 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.

Countries

Israel