Prospective on Market Patient-reported Outcomes for Milli
- Conditions
- VaginismusDyspareunia
- Registration Number
- NCT06397885
- Lead Sponsor
- Materna Medical
- 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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Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Penetration Efficiency Questionnaire 6 months Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as measured by the Penetration Efficiency Questionnaire (Score of ≥2 on PEQ Question #1) at six months
- Secondary Outcome Measures
Name Time Method Penetration Efficiency Questionnaire 3 months, 6 months Improvement in ability to achieve vaginal penetration (intercourse and non-intercourse) as measured by a change in baseline in the overall score on the Penetration Efficiency Questionnaire at 3 and 6 months.
Female Sexual Function Index (FSFI) 3 months, 6 months Improvement in self-reported sexual function as reported on a change in baseline in the Female Sexual Function Index (FSFI) total score at 3 and 6 months.
Numerical Rating Scale 3 months, 6 months Improvement in self-reported pain intensity with intercourse as reported as a change in baseline on a numeric rating scale (NRS) (0= no pain, 10 = worst pain imaginable) at 3 and 6 months
Trial Locations
- Locations (1)
Materna Clinic
🇺🇸Mountain View, California, United States