Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still
lacks a standard of care for optimal treatment. Current treatment options aim to treat the
symptoms associated with VIN and result in a high recurrence rate. Due to the high
reoccurrence rate and the nature of the current treatments, a more effective treatment option
is warranted. An effective treatment that targets only the diseased areas could potentially
decrease recurrence rates. Additionally, a more conservative treatment modality could
contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught.
The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60%
reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.

This study will employ a randomized controlled trial (RCT) design. This is a phase III study
to determine the effectiveness of a more targeted treatment therapy for VIN (comparing
ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified
through the gynecological clinical practices following diagnosis of high grade VIN and will
be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for
multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic
Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of
vulvar dysplasia.

Inclusion Criteria:

- Women 18-89 years old

- Women diagnosed with high-grade VIN (diagnosed by pathology)

- Women referred for vulva sparing treatment for dysplasia

- Women available for follow-up of treatment for 12 months

Exclusion Criteria:

- Women who are pregnant

- Women with low-grade VIN dysplasia (diagnosed by pathology)

- Women with vaginal intraepithelial neoplasia(VAIN)

- Women requiring vulvectomy for treatment

- Women unable to provide informed consent