Treatment of prepubertal labial adhesions: a randomized, double-blinded trial comparing topical emollient versus topical estrogen

Abstract

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 cream, USP, 0.01%; Warner Chilcott). The topical emollient group received Cetaphil® Moisturizing Cream to resemble Estrace® cream. The participants’ parents or guardian were instructed to apply the preparation to the labial adhesion with lateral traction twice daily. The principal investigator, study staff and patients were blinded throughout the trial. The primary outcome was the comparative the effectiveness of topical emollient with lateral traction as compared to topical estrogen with lateral traction on the resolution of labial adhesions in prepubertal girls. The secondary outcome was the change in severity of labial adhesion over time between the two groups. Sample size calculations indicated 20 girls per group would be sufficient (alpha = 0.05, power = 80%). Of the 43 prepubertal girls randomized, 38 (88%) completed the study. Although almost twice as many patients treated with estrogen (37%) had complete resolution of the labial adhesion as compared to those treated with emollient (19%), this difference was not statistically significant (p =.206). In addition, although there was a decrease in severity of labial adhesions with time for both groups, the magnitude of the improvement did not depend on treatment assignment. Seventy-five percent of the variance in severity of labial adhesions between the 2 treatment groups was explained by time alone versus only 2 percent of the variance explained by the interaction between treatment and time. The difference in severity of labial adhesions between the 2 treatment groups over time (interaction effect) and main effect of treatment were not statistically significant (p = .425 and .370 respectively). Topical emollient with lateral traction can be recommended for treatment of prepubertal labial adhesions.