Study data presented at The Menopause Society 2026 Annual Meeting give researchers and clinicians a shared way to tell whether a treatment truly helps women with painful penetration
MOUNTAIN VIEW, Calif., Oct. 21, 2026 /PRNewswire-PRWeb/ -- An 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), the first clinically validated change in score that reflects a real, noticeable improvement for patients.
The analysis 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, presents the findings today as poster P-65 at The Menopause Society 2026 Annual Meeting, held Oct. 20-24, 2026, at the Hilton Bayfront in San Diego.
The PEQ's 3-point 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.
"We are honored to add to the clinical literature on women's sexual health," said Tracy MacNeal, CEO of Materna Medical. "For a woman with vaginismus, what matters is not whether a score moved, but whether she can now use a tampon or have intercourse without pain. Regulators and health plans ask the same question in technical terms: a result may be statistically significant, but is it clinically significant?"
An MCID answers that question by providing a patient-centric approach to objectively measuring the effectiveness of vaginismus treatment.
Key findings
- A gain of at least 3 points on the 0-21 PEQ at three months is the estimated threshold for meaningful improvement in women with vaginismus and painful intercourse.
- The threshold is tied to meaningful pain relief, a drop of at least 2 points on a 0-10 pain scale, and is supported by a second statistical check.
- Women with meaningful pain relief gained 2.7 PEQ points on average; women without it lost 0.3 points.
- The threshold rarely signaled improvement without pain relief: 87% of women without meaningful pain relief stayed below it.
"When a woman tells us she can now insert a tampon or have intercourse without pain, we need a way to measure that change and know it matters," said Sheryl Kingsberg, Ph.D., co-investigator in the POMPOM study. "Anchoring the PEQ to pain relief lets us say that a 3-point gain marks improvement a woman can feel. It gives clinicians and researchers a shared benchmark for treatment response in vaginismus."
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.
Presentation details
- Format: Abstract poster P-65
- Date: Thursday, Oct. 22, 2026
- Time: 6:15-7:15 p.m. PDT
- Location: Indigo West Foyer, Level 2, Hilton Bayfront, San Diego
- Abstract and poster
About the POMPOM study
POMPOM (Prospective On Market Patient-reported Outcomes for Milli; NCT06397885) is a prospective study of patient-reported outcomes in women using Milli for vaginismus (vaginal muscle tightness) 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.
This 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).
At-a-Glance: Technical Data
- Finding: Minimal clinically important difference (MCID) for the Primary Endpoint Questionnaire (PEQ) total score = improvement of at least 3 points from baseline
- Instrument: Primary Endpoint Questionnaire (PEQ), van Lankveld et al., 2006
- Population: 68 women, primarily menopausal; mean age 50.8 years (SD 15.4), median 56.5
- Anchor: Pain during intercourse, 11-point Numeric Rating Scale (NRS, 0-10); responder = prespecified improvement of at least 2 points
- Mean PEQ change, pain responders vs. nonresponders: +2.7 (SD 4.5) vs. -0.3 (SD 3.4); p = 0.0033, Student's t-test
- Pain nonresponders below PEQ threshold (specificity): 27 of 31 (87%)
- Scope: Defines an interpretation threshold for PEQ scores; no comparison group
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.
Our 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.
References
- ClinicalTrials.gov. Prospective On Market Patient-reported Outcomes for Milli (POMPOM). NCT06397885.
- van Lankveld JJDM, et al. J Consult Clin Psychol. 2006;74(1):168-178. doi:10.1037/0022-006X.74.1.168
- Revicki D, et al. J Clin Epidemiol. 2008;61(2):102-109. doi:10.1016/j.jclinepi.2007.03.012
- Prokopowicz, et al. Ginekol Pol. 2022;93(9):686-694. doi:10.5603/GP.a2021.0197
- Reed, et al. J Pain. 2024;25(1):142-152. doi:10.1016/j.jpain.2023.07.028
Media Contact
Tracy MacNeal, Materna Medical, 1 669-649-8486, [email protected], https://www.maternamedical.com/
SOURCE Materna Medical
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