Prospective on Market Patient-reported Outcomes for Milli

Inclusion Criteria:

• Subject is a female at birth aged ≥18 years of age

• Subject is able to read and understand the approved, informed consent form (ICF)

• Subject meets vaginismus and related painful sex/GPPPD criteria as defined in theDSM-5, as confirmed by having one or more of the following for greater than 6months:

• 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

• Subject currently has a sexual partner with a functional penis

• Subject is currently seeking vaginal penetration to achieve sexual intercourse

• Subject is currently unable to tolerate vaginal penetration to achieve sexualintercourse (Score of ≤1 on PEQ Question #1)

• Subject purchased Milli vaginal dilator

• Subject is not contraindicated for Milli vaginal dilator use

• Subject is able and willing to comply with study protocol

Exclusion Criteria:

• Subject has previously participated in any studies by the company in the past 12months or has used Milli prior to enrollment

• Subject is pregnant

• Subject has an active pelvic infection (vagina or vulva)

• Subject has open wounds in the tissue inside or surrounding the vagina

• Subject has an untreated major mental health disorder (e.g., affective disorder,psychosis, PTSD)

• Subject has prior history of gender-confirming surgery, vaginal reconstructionsurgery, pelvic radiation, and/or vaginal procedures that result in extensivescarring (with the exception of hysterectomy procedures)

• Subject or subject's partner experiences other conditions preventing intercourse (e.g., erectile dysfunction, lack of libido)