Dyspareunia Clinical Trial
Official title:
Prospective On Market Patient-reported Outcomes for Milli
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. . ;
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