Focused Ultrasound Therapy of Vulvar Dystrophies: A Feasibility Study

OBJECTIVE:To explore the feasibility and efficacy of focused ultrasound treatment of squamous hyperplasia and lichen sclerosus. METHODS: A simple randomized phase 2 study was conducted in which a total of 76 patients (45 with squamous hyperplasia and 31 with lichen sclerosus) were treated with focused ultrasound therapy from 1999 to 2002. Before and afterthetreatment,thetherapeuticresponseswereevaluated based on changes in clinical symptoms and signs. Pre- and posttreatment biopsy specimens were also assessed through the light and electron microscopic examinations. The positive expressions of CD34 and myelin basic protein (MBP) tests with the strepavidin-peroxidase immunohistochemistry method were used to evaluate the therapeutic response. Statistical analysis was performed using 2 (McNemar 2 ) test and t test. RESULTS: After the ultrasound treatment, clinical symptoms were dramatically improved with a total response rate of 94.74%. Three to 6 months later the skin of treated areas returned to normal appearance. In the 2-year followup, 49 of 76 cases (32 squamous hyperplasia and 17 lichen sclerosus) were cured, 23 (11 squamous hyperplasia and 12 lichen sclerosus) improved and 4 (2 squamous hyperplasia and 2 lichen sclerosus) persisted. The positive expressions of CD34 and MBP after treatment increased significantly at the treated region (P < .05). No major complications occurred. CONCLUSION: Vulvar dystrophy could be effectively treated withfocusedultrasoundtherapy.Thisapproachappearsto be a new promising treatment method, although further studies are still needed. (Obstet Gynecol 2004;104: 915‐21. © 2004 by The American College of Obstetricians and Gynecologists.) LEVEL OF EVIDENCE II-3