Home Diseases and Conditions Vulvar Hyperplasia

Vulvar Hyperplasia

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound for this condition has been researched in clinical trials. However, at this time, we are not aware of any open clinical trials.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with vulvar hyperplasia, which is most often squamous cell, but there are variants. This novel technology focuses beams of ultrasound energy precisely and accurately on targets in the body without damaging surrounding normal tissue. See also “Vulvar Dystrophy.” 

How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling hyperplastic cells to be treated without surgery.

Advantages
The primary options for treatment of vulvar hyperplasia include medication and sometimes invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost.  Focused ultrasound can reach the desired target without damaging surrounding tissue and can also be repeated, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of vulvar hyperplasia.

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

This treatment has been approved by the NMPA in China. Focused ultrasound treatment for vulvar hyperplasia is not yet approved by other regulatory bodies or covered by medical insurance companies.

Notable Papers

Feng T, Wang L, Zhu D, Wu Y, Xie J, Fang L, Du X. Factors influencing the clinical efficacy of high-intensity focused ultrasound in the treatment of non-neoplastic epithelial disorders of the vulva: a retrospective observational study. Int J Hyperthermia. 2021;38(1):1457-1461. doi: 10.1080/02656736.2021.1985628.

Krapf JM, Mitchell L, Holton MA, Goldstein AT. Vulvar Lichen Sclerosus: Current Perspectives. Int J Womens Health. 2020 Jan 15;12:11-20. doi: 10.2147/IJWH.S191200. eCollection 2020.

Ye M, Deng X, Mao S, Xue M. High intensity focused ultrasound treatment for non-neoplastic epithelial disorders of the vulva: Factors affecting effectiveness and recurrence. Int J Hyperthermia. 2015;31(7):771-6. doi: 10.3109/02656736.2015.1053101. Epub 2015 Sep 14.

Liming Ruan, Zhenwei Xie , Huiyun Wang, Jingyi Jiang , Haiyan Shi , Jian Xu. High‐intensity focused ultrasound treatment for non‐neoplastic epithelial disorders of the vulva. Intl J of gyn/OB. First published: 13 February 2010 https://doi.org/10.1016/j.ijgo.2009.12.014

Click here for additional references from PubMed.