An interim vaginismus analysis proposes a three-point questionnaire benchmark. Understand the findings, study limits and questions to ask about meaningful change.
On October 21, 2026, Materna Medical announced an interim analysis proposing a benchmark for meaningful improvement in women with vaginismus and painful intercourse. The company-funded POMPOM study was presented at The Menopause Society’s 2026 Annual Meeting in San Diego. Its central question concerned a questionnaire: when does a changed score represent an improvement that matters to the person completing it?
According to Materna Medical, the analysis proposed a gain of at least 3 points on the Primary Endpoint Questionnaire, or PEQ. Researchers call this kind of threshold a minimal clinically important difference, often shortened to MCID. The proposal concerns how to interpret a score rather than simply recording that the score moved.
That distinction matters when reading sexual wellness research. A numerical change and a personally meaningful change are related questions, but they are not interchangeable.
The company’s report describes an interim three-month analysis involving 68 women who used Milli, a vaginal dilator. The sample was primarily menopausal. Participants had a mean age of 50.8 years and a median age of 56.5.
Study co-investigator Sheryl Kingsberg, Ph.D., presented the findings as poster P-65 at the meeting. The analysis examined changes in participants’ questionnaire scores alongside changes in their reported pain.
Materna Medical describes the PEQ as covering seven types of vaginal penetration. Examples include tampon insertion, finger insertion and intercourse with a partner. Each activity receives a score from 0 for “not attempted” to 3 for “always successful.” The total score runs from 0 to 21.
This questionnaire therefore brings several activities into a combined score. It is not simply a rating of pain during intercourse. Understanding that distinction is essential before interpreting the proposed threshold.
The research question was whether improvement across those activities could be connected to a specified improvement in pain. That connection supplied the basis for the proposed meaningful-change benchmark.
To develop the benchmark, the researchers used a reduction of at least 2 points on a pain scale running from 0 to 10. This was the analysis’s pain-improvement criterion. They then compared PEQ changes between women who met that criterion and those who did not.
According to the company release:
The release reports a statistical result of p = 0.0033 for the comparison in PEQ change. The proposed gain of at least 3 points was intended to help translate the questionnaire results into a meaningful-change category.
The important feature is the link between different reports from participants. The analysis did not treat any upward movement in the questionnaire score as equally meaningful. Instead, it related the score change to a defined improvement in pain.
Materna Medical offered an example of how a three-point gain might occur: moving from “sometimes” to “always” successful on three activities. That illustrates how points can accumulate across the questionnaire. It is not a description of what every participant experienced.
A combined score also leaves an important question for interpretation: which activities changed? The total provides a summary, while the individual answers supply the detail needed to understand that summary.
The analysis had no comparison group. It therefore does not establish that Milli caused improvement or that it works better than another treatment or no treatment. Materna Medical’s release describes the analysis as establishing a score-interpretation benchmark rather than measuring treatment effect.
That design cannot separate the device’s contribution from other possible influences on change. The reported association between pain improvement and questionnaire improvement answers a measurement question. It does not settle a treatment-effectiveness question.
The total PEQ score was also an exploratory endpoint. POMPOM’s primary endpoint was successful vaginal intercourse, measured through PEQ item 1. The proposed benchmark comes from examining the broader questionnaire total rather than the study’s primary outcome alone.
The source and stage of the findings deserve attention as well. These are company-reported interim results from a company-funded study, described in a news release about a conference poster. Kingsberg’s comments about a shared benchmark represent an investigator’s interpretation, not independent confirmation of broad validation.
The sample’s primarily menopausal makeup also limits how confidently the proposal can be extended to other populations. A threshold developed in this setting should not automatically be assumed to apply across different ages, treatments or clinical circumstances.
Materna Medical says a six-month analysis is planned to examine the threshold against additional measures. These include the pain domain of the Female Sexual Function Index, or FSFI. That further assessment and independent publication would be important before treating the proposed threshold as broadly established.
For clinical background, the Merck Manual provides a patient overview of painful sex in women. POMPOM addresses a narrower research question within that broader subject: how much movement on a particular questionnaire should count as meaningful improvement?
This is a different task from describing a condition or assessing treatment options. A meaningful-change threshold helps interpret an outcome after it has been measured. Its value lies in making research results easier to understand in terms that connect with patients’ experiences.
Kingsberg’s explanation emphasized outcomes such as being able to insert a tampon or have intercourse without pain. Those examples show why a questionnaire needs to connect with recognizable experiences rather than remain an abstract total.
For the primarily menopausal sample in this analysis, the proposal also sits alongside wider questions about sexual comfort during midlife. Sexential’s guide to hormonal and nonhormonal options in context addresses that separate treatment discussion. The benchmark concerns how improvement is measured within research, not which option an individual should choose.
The useful development here is the attempt to give a score clinical meaning. It places attention on whether the measured change connects with an experience that matters, rather than treating numerical movement as the whole story.
For someone experiencing painful penetration, the practical significance is a clearer set of questions about outcomes. The proposed threshold can help frame a conversation about research without becoming a personal target or a self-assessment rule. Decisions about an individual concern belong in a discussion with a qualified clinician.
Several questions follow directly from the analysis.
A pain rating and a questionnaire about completing activities describe different aspects of an experience. In this analysis, researchers used the relationship between them to develop the proposed threshold. Asking which outcome a study measures helps clarify what its result actually means.
The same question is useful when discussing care: is the conversation about pain, the ability to complete a particular activity or a broader concern about sexual wellbeing? Naming the outcome keeps the discussion specific without assuming that every concern is identical.
The questionnaire combines several activities, but their personal importance may differ. A discussion about meaningful improvement can therefore include which activity matters to the person and why. The combined total is a starting point for that conversation rather than its full content.
The “not attempted” response also calls for context. It records what was reported on the questionnaire, while the reason behind that answer remains a separate question. Reading a score carefully means leaving room for the person’s explanation.
In this analysis, the proposed PEQ threshold was tied to a specified reduction in pain. Readers can ask what a study used as its reference point for meaningful change. That is more informative than assuming that every reported score increase has the same significance.
It is also reasonable to ask how a study distinguishes improvement that is measurable from improvement that patients notice. This announcement makes that distinction its central subject.
When evaluating a treatment claim, ask what the treatment was compared with. This question helps keep evidence about interpreting outcomes separate from evidence about the effects of treatment. Both questions matter, but they require different kinds of analysis.
For partners, the wider conversation need not become a test of completing activities or reaching a score. Sexential’s discussion of mutual comfort rather than universal benchmarks offers a relationship-focused perspective on that distinction. A research measure has a defined purpose; a couple’s conversation can make room for their own priorities.
Return to the questionnaire at the center of this announcement. A changed total becomes more useful when it is connected to the activity that changed and the experience behind the answer. The promise of a meaningful-change benchmark is not that it replaces that conversation, but that it gives the conversation a clearer starting point.
Following a questionnaire score is only part of a clinician’s conversation about painful penetration; Sexential places that measurement in a wider educational context. Its mature sexual wellness reporting considers biology alongside confidence and relationships, with information for midlife readers rather than individual medical direction.
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