Materna Medical Announces Promising Early Findings from Online Study of Women Experiencing Vaginal Muscle Tightness and Painful Intercourse

Yahoo

27-02-2025

Baseline Data Reveals Compelling Characteristics of this Understudied Patient Population
MOUNTAIN VIEW, Calif., February 27, 2025--(BUSINESS WIRE)--Materna Medical, Inc., a leading innovator in women's pelvic health solutions, today announced the presentation of baseline data from the ongoing observational clinical trial Prospective On Market Patient-reported Outcomes for Milli™ Vaginal Dilator (the POMPOM study) at the International Society for the Study of Women's Sexual Health (ISSWSH) Annual Clinical Meeting in Atlanta, Georgia, from February 27 to March 2, 2025.
The abstract, titled "Online Observational Clinical Trial for Assessing the Effectiveness of an FDA-Cleared Expanding Dilator #188," is presented as an e-poster by POMPOM Principal Investigator, Sheryl Kingsberg, Ph.D., Professor, Departments of Reproductive Biology, Psychiatry, and Urology, Case Western Reserve University School of Medicine.
This groundbreaking clinical investigation is gathering valuable data on the effectiveness of the Milli Vaginal Dilator to help relieve the symptoms of vaginal muscle tightness and painful intercourse. Milli is a modern, all-in-one expanding dilator with optional vibration.
Participants were invited to join POMPOM after self-determining the relevant medical conditions1 and enrolled using a remote online data collection process. The virtual, secure, and confidential format allows convenient and discreet participation, making research accessible to a broad population.
Using the POMPOM study's remote platform, 74 qualified subjects enrolled after self-diagnosing their vaginismus and purchasing the Milli Expanding Vaginal Dilator online.1
Initial findings reveal:
Over two-thirds (70.3%) of the participants had reported symptoms associated with vaginal muscle tightness for over 3 years (23.0% for 3-5 years) and 47.3% for over 5 years.
In addition to the duration of their symptoms, 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."
Millions of People Are Affected
Vaginal muscle tightness (vaginismus) is a common yet underreported condition that affects 5-17% of people assigned female at birth at any time in their life.2 The condition is characterized by involuntary muscle contractions of the vaginal wall, making sexual penetration painful, challenging, and impossible. Those afflicted often do not realize this is a treatable medical condition, that help is available, and they are not alone.
Materna's Solution
The all-in-one Milli Expanding Vaginal Dilator with vibration addresses this condition to support patients suffering from vaginal muscle tightness and related painful sex. In 2019, the Milli device was launched as a wellness trainer and, in 2023, received FDA clearance* to sell over the counter, enabling streamlined access to people suffering from vaginal muscle tightness (vaginismus) and painful intercourse (dyspareunia).
"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 the initial Milli Vaginal Dilator data previously published in the April 2021 issue of Sexual Medicine Reviews, Vaginal Dilators: Issues and Answers.3 For more information, visit https://hellomilli.com/pompom.
About Materna Medical
Materna Medical is a novel OBGYN platform company defining a $25B market with core technologies addressing unmet needs in women's pelvic health. With headquarters in Mountain View, California, Materna pulls from the top minds in MedTech to truly transform the standard of care in OBGYN. With a diverse team of engineers, scientists, researchers, and commercial leaders, Materna Medical's mission is to empower women to protect their pelvic health.
Materna's second product, Materna Prep, is an investigational device used during labor and is intended to reduce pelvic floor muscle injury during vaginal delivery. This product is being studied in the EASE trial, a large, randomized controlled trial running in 20 top US hospitals. Materna aims to transform the standard of care in labor and delivery by protecting pelvic floor health for moms.
*Indication Statement: The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
1Tucker S, Javaid S, Rubin R. Accuracy of online patient self-diagnosis of vaginismus/genito-pelvic pain/penetration. Presented at: 25th Annual Fall Scientific Meeting of SMSNA. Scottsdale, Arizona. October 17-20, 2024.
2Melnik, T., Hawton, K., & McGuire, H. (2012). Interventions for vaginismus. Cochrane Database of Systematic Reviews, 2012(12), CD001760.
3Liu M, Juravic M, Mazza G, Krychman ML. Vaginal Dilators: Issues and Answers. Sex Med Rev. 2021 Apr;9(2):212-220. doi: 10.1016/j.sxmr.2019.11.005. Epub 2020 Jan 31. PMID: 32014450.
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Contacts
Media Contact: Debbie DonovanHead of Commercial OperationsMaterna Medical, [e-mail]