Materna Medical launches POMPOM study to explore treatment for vaginismus with Milli Vaginal Dilator

Materna Medical, Inc., a leader in women’s pelvic health solutions, has initiated the Prospective On Market Patient-reported Outcomes for Milli Vaginal Dilator (POMPOM) study. This pioneering clinical investigation aims to assess the effectiveness of the Milli Vaginal Dilator in alleviating symptoms of vaginismus and related painful intercourse, conditions that affect millions worldwide.

Addressing the Underreported Condition of Vaginismus

Vaginismus, a condition that causes involuntary muscle contractions of the vaginal wall, makes sexual penetration difficult or impossible for 5-17% of individuals assigned female at birth. Despite its prevalence, vaginismus remains largely underreported and untreated due to lack of awareness and available research, particularly when compared to male sexual dysfunction.

“Unlike the well-funded and researched treatments available for male sexual dysfunction, there is a critical gap in the research on medical interventions for vaginismus,” explained Tracy MacNeal, CEO of Materna Medical. The POMPOM study seeks to bridge this gap by providing crucial data on the Milli Vaginal Dilator, a discreet, convenient at-home device designed to manage this common yet overlooked condition.

The Innovative Approach of the Milli Vaginal Dilator

First introduced as a wellness trainer in 2019 and receiving FDA clearance in 2023 for over-the-counter sales, the Milli Vaginal Dilator represents a significant advancement in the treatment of vaginismus. This device allows individuals to manage their condition privately and effectively, offering hope to those suffering from the associated discomfort and emotional distress.

Call for Participation in the POMPOM Study

Materna Medical is currently seeking participants for the POMPOM study, registered under ClinicalTrials.gov (NCT06397885). This research is conducted in a virtual, secure, and confidential format, enabling broad participation from individuals experiencing symptoms of vaginismus.

Sheryl Kingsberg, Ph.D., the study’s Principal Investigator and Professor at Case Western Reserve University School of Medicine, emphasized the importance of participation: “By joining this study, Milli users will contribute to a better understanding of how to support women with vaginismus and associated painful intercourse. With new technological advances in pharmacology and devices like the Milli Vaginal Dilator, we are closer than ever to providing relief from this debilitating condition.”

In conclusion, the launch of the POMPOM study by Materna Medical marks a critical step forward in addressing the treatment disparities in women’s sexual health. This study not only aims to validate the effectiveness of the Milli Vaginal Dilator but also to enhance the understanding and treatment of vaginismus, potentially transforming the lives of many affected by this condition.