Clinical trial NCT06397885: Prospective on Market Patient-reported Outcomes for Milli
Official title: Prospective on Market Patient-reported Outcomes for Milli
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vaginismus
Dyspareunia
Keywords: painful sex
dilation
Lead sponsor: Materna Medical
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population shall include subjects seeking relief for the symptoms of vaginismus and/or associated dyspareunia (painful sex).

The Milli Vaginal Dilator is cleared for use as an Over-The-Counter device (K220035). As such, the study population shall be comprised of all adult subjects who provide (≥18 years of age) Informed Consent.

Brief summary: To assess the effectiveness of the Milli device in achieving vaginal intercourse

Detailed description: The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion.

This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available, over-the-counter medical device.

The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement:

The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

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Eligibility criteria: 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 the DSM-5, 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
* 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 sexual intercourse (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 12 months 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 reconstruction surgery, pelvic radiation, and/or vaginal procedures that result in extensive scarring (with the exception of hysterectomy procedures)
* Subject or subject's partner experiences other conditions preventing intercourse (e.g., erectile dysfunction, lack of libido)

Primary outcomes:
measure: Penetration Efficiency Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Penetration Efficiency Questionnaire
timeFrame: 3 months
measure: Penetration Efficiency Questionnaire
timeFrame: 3 months, 6 months
measure: Female Sexual Function Index (FSFI)
timeFrame: 3 months, 6 months
measure: Numerical Rating Scale
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Materna Clinic
state: California
Study officials:
affiliation: Materna Clinic
name: Sheryl Kingsberg, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: