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Join the POMPOM Clinical Study and Share Your Milli Experience

By participating in this study, you will be contributing valuable research that will help clinicians learn more about how to help women with vaginismus and associated painful sex. Your contribution is a meaningful step towards a better future for those facing these challenges.

We are confidentially and remotely collecting data with questionnaires to track changes in these key dimensions: pain, sexual and emotional well-being, Milli Vaginal Dilator satisfaction, and usage (frequency, time, vibration).

This study will not require in-person office visits—we call these “Virtual Visits.” We will provide you with access to a study physician when requested. All questionnaires will be sent via email with a link to complete electronically. Here’s what you can expect from the POMPOM study:

  • POMPOM study consent—to review, click here.
    • If you want to join the POMPOM study, electronically sign the consent form.
    • If you have any questions about the study or the consent form, we will connect you with a study physician for further explanation.
  • Next, you will receive emails with a link to questionnaires to confirm your eligibility and collect baseline information, including the date of first use.
  • At specific time intervals—3 months (checkpoint) and 6 months (exit)—you will receive an email with a link to the same questionnaires.
  • For your time, we will pay you $100 for each completed questionnaire set—baseline, 3-month (checkpoint), and 6-month (exit).
  • Between the above intervals, we will send an email touchpoint confirming that you wish to continue participating in the study. Those touchpoints also allow you to speak to a study physician or exit the study with a final set of questionnaires.
  • You are eligible to participate in the POMPOM study once you purchase Milli and meet the inclusion and exclusion criteria. Please review the table below to determine if you are eligible.

The information you provide will be aggregated and reported to clinicians to learn more about how to help women with vaginismus and associated painful sex.

The Milli Vaginal Dilator is an FDA-cleared medical device with permission to sell over-the-counter (no prescription required).

We hope you will join the POMPOM study. Cheers to improved sexual health for everyone!

Inclusion Criteria
you may participate in POMPOM if:

Exclusion Criteria
you may NOT participate in POMPOM if:

  • You are a female at birth aged ≥18 years of age.
  • You purchased a Milli Vaginal Dilator
  • Used Milli before enrollment.
  • You have previously participated in any studies by the company in the past 12 months
  • You currently have a sexual partner with a functional penis
  • You are currently seeking vaginal penetration to achieve sexual intercourse
  • You are currently unable to tolerate vaginal penetration to achieve sexual intercourse
  • You are currently pregnant
  • You or your partner experiences other conditions preventing intercourse (e.g., erectile dysfunction, lack of libido).
  • You meet vaginismus and related painful sex criteria (genito-pelvic pain/penetration disorder) as confirmed by having one or more of the following for greater than 6 months:
    • Pelvic pain
    • Vaginal pain
    • Pain with vaginal intercourse
    • Pain with vaginal penetration
    • Fear or anxiety about vaginal or pelvic pain with vaginal penetration
    • The inability to achieve vaginal penetration
  • You have a prior history of any of the following:
    • gender-confirming surgery
    • vaginal reconstruction surgery
    • pelvic radiation
    • vaginal procedures that result in extensive scarring
  • EXCEPT hysterectomy procedures
  • You have active pelvic infections.
  • You have open wounds in the tissue inside or surrounding the vagina.
  • You are able to read and understand the approved informed consent form (ICF).
  • You are able and willing to comply with the study protocol.
  • You have an untreated major mental health disorder (e.g., affective disorder, psychosis, PTSD)