Materna Medical Establishes Benchmark for Measuring Improvement in Vaginismus Treatment

MOUNTAIN VIEW, Calif., Oct. 21, 2026 /CourierPR/ -- Materna Medical has announced a significant breakthrough in the measurement of meaningful improvement for women suffering from vaginismus, a condition characterized by painful penetration. The company's findings, presented at The Menopause Society 2026 Annual Meeting, provide a shared benchmark for researchers and clinicians to determine whether a treatment truly benefits women experiencing painful intercourse.

The interim three-month analysis from the Materna Medical-funded POMPOM study, NCT06397885, identified a 3-point minimal clinically important difference (MCID) on the 0-21 Primary Endpoint Questionnaire (PEQ). This threshold marks the first clinically validated change in score that reflects a real, noticeable improvement for patients. The study included 68 women who used Milli, an FDA-cleared, precision-engineered expanding vaginal dilator designed for controlled, progressive dilation.

Sheryl Kingsberg, Ph.D., chief of behavioral medicine in the Department of Ob/Gyn at University Hospitals Cleveland Medical Center and a co-investigator in the POMPOM study, presented the findings at the meeting.

The Primary Endpoint Questionnaire (PEQ) asks women how often they can complete seven types of vaginal penetration, such as inserting a tampon, a finger, or intercourse with a partner. Each type is scored from 0 (not attempted) to 3 (always successful). A 3-point gain could mean, for example, moving from "sometimes" to "always" successful on three activities. The analysis revealed that women with meaningful pain relief gained an average of 2.7 PEQ points, while those without it lost 0.3 points. The threshold rarely signaled improvement without pain relief: 87% of women without meaningful pain relief stayed below it.

The MCID sets the point at which a score change matters to the patient. Until now, no MCID had been established for the PEQ, so studies could report score changes but not whether those changes mattered to the women reporting them. The threshold gives clinicians and researchers a shared benchmark: it separates real progress from ordinary variation and lets studies report how many women achieved a meaningful improvement.

The POMPOM (Prospective On Market Patient-reported Outcomes for Milli; NCT06397885) study is a prospective study of patient-reported outcomes in women using Milli for vaginismus and related dyspareunia (painful intercourse). Successful vaginal intercourse, measured by PEQ item 1, is the primary endpoint; the total PEQ score is an exploratory endpoint. The interim analysis had no comparison group, so it sets a benchmark for interpreting scores rather than measuring treatment effect. A planned six-month analysis will test the 3-point threshold against additional measures, including the pain domain of the Female Sexual Function Index (FSFI).

Materna Medical, a novel OBGYN platform company, is defining a $25 billion 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. The company's first product, Milli™, is a vaginal dilator to support patients suffering from vaginismus and related painful sex. In 2019, the Milli device launched as a wellness trainer and, in 2023, received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes have been studied in a post-market prospective virtual study named POMPOM.

Materna's second product, Ellora™, is an investigational device used during labor and is intended to reduce pelvic floor muscle injury during vaginal delivery in first-time moms. This product is being studied in the EASE trial, a large, randomized controlled trial in 20 top US hospitals. Materna aims to transform the standard of care in labor and delivery by protecting pelvic floor health for moms.