Novel Hydrogel Film to Reduce Pain Experienced during Sexual Intercourse for Women with Vulvodynia

Pelva Health Corporation, Edina MN

Investigators

Abstract

The goal of this project is to develop a non-pharmaceutical hydrogel film and corresponding applicator delivery system that helps mitigate pain receptor activity during sexual intercourse for women with gynecologic pain conditions, specifically vulvodynia and vestibulodynia. Several solutions exist that attempt to eliminate vulvar pain, but their designs fall short. Pharmaceuticals such as opiates, anesthetics, anticonvulsants, estradiol, and antidepressants are commonly prescribed to patients diagnosed with vulvodynia and vestibulodynia; however, none of these have been indicated for vulvodynia by the FDA and have an overall lack of validation. Additionally, these pharmaceutical options often have negative consequences on patients and do not guarantee immediate and safe pain-relief during sexual intercourse, especially with continual use. Although etiology of vulvodynia is still unknown, we do know that vulvodynia is triggered by pressure on sensitive nociceptors, especially located in the vaginal vestibule. Reducing pressures on sensitive tissue has been shown to eliminate the sensation of pain, but there are currently no solutions that reduce the forces on vulvar tissue during sexual intercourse. Pelva Health proposes the development of a force dissipating hydrogel film that reduces pressure on the vulva, vestibule, and vagina will allow for immediate pain-free sexual intercourse. Once developed, our hydrogel film and corresponding applicator will be studied clinically for effectiveness in mitigating pain experienced during sexual intercourse by women with vulvodynia and vestibulodynia in a Phase II clinical study. With no technology currently indicated for vulvodynia and vestibulodynia with the Food and Drug Administration, Pelva Health has potential to undergo breakthrough designation for the first ever device indicated for vulvodynia and vestibulodynia.