To assess the effectiveness of the Milli device in achieving vaginal intercourse
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. .
Study Type
OBSERVATIONAL
Enrollment
200
Patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion
Materna Clinic
Mountain View, California, United States
Penetration Efficiency Questionnaire
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
Time frame: 6 months
Penetration Efficiency Questionnaire
Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as
Time frame: 3 months
Penetration Efficiency Questionnaire
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.
Time frame: 3 months, 6 months
Female Sexual Function Index (FSFI)
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.
Time frame: 3 months, 6 months
Numerical Rating Scale
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
Time frame: 3 months, 6 months
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