Prepubertal Labial Adhesions Clinical Trial
Official title:
Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen.
This study aims to evaluate an alternative and less costly option of treatment with
potentially less side effects.
Primary Hypothesis:
There will be a difference in complete resolution of labial adhesions with topical estrogen
with lateral traction as compared to an emollient with lateral traction.
The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in
combination with vulvar irritation. For many years, first-line treatment for labial adhesions
in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of
labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of
treatment. However, because topical estrogen is systemically absorbed, its use is associated
with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There
is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical
estrogen. In addition, topical estrogen is costly. Therefore, there continues to be
controversy over the optimal treatment of labial adhesions in prepubertal girls.
Generally, for medical treatment of labial adhesions, topical estrogen is applied to the
adhesion whist applying gentle lateral traction to promote separation of the labia. It is,
therefore, plausible that the lateral traction applied to the adhesion site is what
ultimately results in the separation of the labial fusion, while the use of estrogen improves
healing after mechanical separation.
This is a single site, prospective, randomized, double-blinded study evaluating the
comparative effectiveness of topical estrogen with lateral traction versus topical emollient
with lateral traction for the treatment of labial adhesions in prepubertal girls.
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