151 Milli™; the Only Patient Controlled Expanding Dilator Results from the Initial Launch

Abstract

Dilators are poorly characterized in the scientific literature yet may facilitate reconditioning the brain body reconnection for anticipatory anxiety. Some post-menopausal women experiencing dyspareunia use vaginal dilators to facilitate penetrative intercourse with less pain. However, women often report of decreased compliance, burdensome regimes, and excessive time commitments as well as concern about stepwise abrupt transitioning from one size to another. Milli is a patient controlled electronically dilator that expands 1 mm at a time that attempts to rectify many of these dilemmas. The secondary launch (n=130) of this novel dilator is reported here. The Milli device was available for a selected group of patients seen by a diverse group of sexual medicine specialists. Each Milli patient participated in a phone interview, introduction survey (n=130) and 3-month follow-up survey (n=80 collected). Patients were offered the device at a 50% discounted retail price for anonymous participation. Milli is designed to be inserted at the smallest diameter (15mm), and expand in 1 mm slow patient-controlled increments to a maximum diameter of 40mm. The most common goals for patients were: return to penetrative intercourse and pain reduction during coitus. Patients saw their clinician on average every 13 weeks (range 1-52 weeks) Outcomes monitored included: 1) return to intercourse (27% of non-active returning to intercourse) 2) reduction in pain scores 0-10 (1.5 point reduction) 3) Increase in Milli Diameter (7.1mm) and 4) subjective feedback regarding progress toward goals (89% reported progress). 60% of patients had suffered from their medical condition for >2 years, 25% haven’t been sexually active for >5 years, and 73% engaged in penetrative sex despite experiencing pain. Patients used Milli on average 3 days/week. The most common emotions patients to describe their treatment were “anxious”, “frustrated”, yet “empowered” and “optimistic”. The average dilatory session was 15 minutes, mostly in the evening /bedtime (75%), in the bedroom (90%). Women most often watched TV, videos, read, listened to soothing music while dilating. Only 27% have used their dilators with their partners before coitus, 83% of those patients were post-menopausal. There were no serious adverse events reported. All participants reported that Milli was superior to conventional dilators because of the ability to expand while already inserted and smaller increments resulted in improved confidence. The optional vibration feature (used by 87% of patients) and aesthetically pleasing silicone cover design (soft, easy to clean) were also positive attributes. Factors that showed trends to improved patient outcomes were use of vibration, length of Milli treatment (>3 months), dilation sessions >15min, dilating with their partners prior to intercourse, and use of candles and soothing music.