(030) HUUDDII: THE CLITORAL SUCTION DEVICE

Abstract Introduction Clitoral blood flow plays an important role in female sexual arousal and overall sexual satisfaction. Typically, sexual arousal results in smooth muscle relaxation and arterial vasodilation within the clitoris. The result is an increase in blood flow and intra-cavernous pressure leading to tumescence and extrusion of the glans clitoris. Several health conditions can impact this mechanism, leading to decreased sexual desire, arousal, orgasm, and satisfaction. Huuddii is a simple, hands-free, disposable product that fits over the clitoris and improves sexual function by combining initial gentle suction and frictional force that stimulates the clitoris and activates the sexual arousal cascade. Huuddii underwent a multicenter non-significant risk clinical and over-the-counter (OTC) label comprehension 510 k study for FDA approval in 2004-2005. The label comprehension test portion of the study was designed to test subject’s ability to correctly self-select for use of this product to treat symptoms related to female sexual dysfunction and understand and correctly use the product as outlined in the consumer instruction guide. The clinical portion of the study was designed to test the safety and efficacy of the device in an OTC environment. Objective To assess the clinical efficacy, safety, and user-friendly nature of Huuddii in improving female sexual function with the goal of OTC FDA approval. Methods Objective data was collected using the Female Sexual Function Index (FSFI). Subjects completed an FSFI questionnaire as a baseline and after device utilization. Subjective data was collected using the Sexual Life Quality Questionnaire (SLQQ) and Female Intervention Efficacy Index (FIEI). The SLQQ and FIEI were completed post-intervention. Results Our objective results as measured by the FSFI revealed that individual success was achieved in “overall improvement in sexual function” in 87% of subjects. Percentages for the following sub-domains of “desire,” “arousal,” “lubrication,” “orgasm,” “satisfaction,” and “pain” were 63%, 92%, 82%, 84%, 79%, and 55%, respectively. Subjective result, 87% of subjects who completed the SLQQ reported improved sexual quality of life and satisfaction while wearing Huuddii. Results of the FIEI demonstrated a 74% improvement in lubrication, 82% increase in genital sensitivity, 66% increase in pleasure associated with intercourse, 63% improvement in orgasm, and 82% increase in overall sexual satisfaction. Ninety-two percent (92%) of subjects claimed they would like to continue using the device after the study was completed. Conclusions Huuddii is a safe, simple, disposable, non-invasive suction cup that assists in achieving and maintaining clitoral tumescence, increases blood flow to the clitoris, and ultimately enhances female sexual function. Disclosure No.