Materna Medical, a company focused on women’s pelvic health solutions, has announced baseline data from its ongoing POMPOM (Prospective On Market Patient-reported Outcomes for Milli Vaginal Dilator) observational clinical trial. The findings were presented at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Clinical Meeting in Atlanta, Georgia, taking place from February 27 to March 2, 2025.
The abstract, “Online Observational Clinical Trial for Assessing the Effectiveness of an FDA-Cleared Expanding Dilator #188,” was presented as an e-poster by POMPOM Principal Investigator, Sheryl Kingsberg, Ph.D., Professor, Departments of Reproductive Biology, Psychiatry, and Urology at Case Western Reserve University School of Medicine.
The clinical investigation is gathering data on the effectiveness of the Milli Vaginal Dilator in helping to relieve symptoms of vaginal muscle tightness and painful intercourse. The study utilizes a remote online data collection process, allowing participants to enroll after self-determining relevant medical conditions.
Through the virtual platform, 74 qualified subjects enrolled after self-diagnosing their vaginismus and purchasing the Milli Expanding Vaginal Dilator online. The initial findings from the study revealed several important characteristics of this patient population:
- Over two-thirds (70.3%) of participants had reported symptoms associated with vaginal muscle tightness for over 3 years, with 23.0% experiencing symptoms for 3-5 years and 47.3% for over 5 years.
- 45.9% of subjects had seen at least 2 healthcare providers for evaluation and treatment.
- Over a quarter (28.4%) of participants reported severe symptoms, including a visceral reaction – extreme nervousness, palpitations, tremors, hyperventilation, sweating, and shaking – during penetration for a standard pelvic exam.
- The majority (62.2%) had not given birth to children (nulliparous).
- While most were new to dilator therapy, 43.3% reported a history of static dilator use.
“Study participants enrolled quickly, and their full participation has exceeded our expectations. These early findings confirm the significant unmet need and highlight the potential of online platforms to overcome barriers to care,” said Dr. Kingsberg. “By providing convenient and discreet access to information, support, and treatment options, we can empower women to take control of their sexual health and well-being.”
According to the company, vaginal muscle tightness (vaginismus) affects 5-17% of people assigned female at birth at any time in their life. The condition is characterized by involuntary muscle contractions of the vaginal wall, making sexual penetration painful, challenging, and sometimes impossible.
The Milli Expanding Vaginal Dilator with vibration is described as an all-in-one solution that addresses this condition. The device was launched as a wellness trainer in 2019 and received FDA clearance in 2023 to sell over the counter, enabling streamlined access for people suffering from vaginal muscle tightness and painful intercourse.
“It’s interesting to note that 43% of the self-selected subjects have experience using traditional static dilators, either currently or used in the past. This suggests that patients are seeking more modern, innovative treatment options for their pelvic health conditions,” said Tracy MacNeal, CEO of Materna Medical. “The POMPOM study is generating data to support the effectiveness of the all-in-one Milli Expanding Vaginal Dilator with vibration, a discrete, convenient, at-home solution for managing this common condition. We are committed to developing innovative solutions that improve women’s lives affected by pelvic health conditions.”
The POMPOM study builds on initial Milli Vaginal Dilator data previously published in the April 2021 issue of Sexual Medicine Reviews in an article titled “Vaginal Dilators: Issues and Answers.”
