The safe proprietary, patented materials address multiple mechanisms of action including physical and mechanical interactions with the vaginal wall, time-controlled cooling that treats the infection, stops symptoms, promotes the microbiome & pH, and breaks up biofilms. Biofilms make the infections hard to treat by drugs. Place the Vlisse device in the freezer for 2 hours, rinse briefly in tap water, insert for 30 minutes sitting or lying down with the loop barely visible at the vaginal opening. You can control the amount of cooling by pushing it further inside the vagina if it seems too cold. Remove and discard after 30 minutes. Repeat twice daily for 3 days.

Designed to be a non-systemic, low-risk option, Vlisse is inserted similarly to a tampon. Two studies have been completed, with 2 more ongoing, and no device-related adverse events have been reported.

It should not recur unless there is a trigger which would be an environmental change such as elevation in pH (BV), heat, antibiotics, excess glucose, pregnancy, or steroid used—and a few others. Since we have some data that Candida and bacteria are eradicated with the device, then GI exposure (recolonization of the vagina from the bowel) and sexual activity could increase the risk. However, Candida and bacteria inhabit the vagina normally-- Candida is present in the vagina in up to 70% of asymptomatic women.

VLISSE is currently an investigational device completing its pivotal FDA trial.  One small-published trial demonstrated high efficacy. The final results will be available this summer.

No. A larger clinical trial is underway for FDA clearance. VLISSE has been studied in >100 women with no major safety concerns and early demonstration of efficacy to achieve clinical cures and provide rapid symptom relief. VLISSE remains investigational and is not currently available for sale.