TREATMENT OF PREPUBERTAL LABIAL ADHESIONS: A RANDOMIZED, DOUBLE BLINDED TRIAL COMPARING TOPICAL EMOLLIENT VERSUS TOPICAL ESTROGEN A THESIS IN Bioinformatics

Labial adhesions are a common finding estimated to occur in 22% of prepubertal girls. Symptoms are related to the accumulation of urine behind partially fused labia and include urinary tract infections, vulvovaginitis, pain with activity, post-void dripping of urine, and, in cases of complete labial fusion, urinary retention. Although topical estrogen had traditionally been considered first-line therapy, this method of treatment can be associated with alarming side effects in prepubertal girls including breast budding and vaginal bleeding. This clinical study aimed to assess the need for estrogen for treatment of prepubertal labial adhesions. A single site, randomized, double-blinded, 21-month clinical trial was performed. Prepubertal girls ages 3 months to 12 years with labial adhesions and without underlying dermatologic disorders, systemic conditions that can have vulvar manifestations, disorders requiring immunosuppressant treatment, and previous surgical separation of labial adhesions were included in the study. A computer-generated block randomization design with blocks of 10 was used to randomize participants into the topical estrogen or topical emollient group. The topical estrogen group received Estrace® Cream (Estrace vaginal