Dyspareunia, Vaginismus
Conditions
Keywords
painful sex, dilation
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. .
Interventions
DEVICEMilli Vaginal Dilator
Patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion
Sponsors
Materna Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Penetration Efficiency Questionnaire | 3 months | Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as |
| 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. |
Countries
United States
Outcome results
None listed