FAQs

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 1-2 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 at least once within 24 hours. It may only require 2-3 uses.

It has undergone two studies and two more are ongoing. It is a low-risk device (Class II) and safer than tampons and menstrual cups. No adverse effects have occurred.

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.

Over 90% clinically proven.

No. A larger clinical trial is underway for FDA clearance. It is considered a low-risk, safe device. Over 30 women have used the device safely and successfully. It's not available for sale.

Because any hint of symptoms would prompt use and be able to prevent the bud to hyphae switch. That would stop the intense inflammatory response before it could take hold. Also, for recurrent sufferers, there are multiple preventative strategies that could be employed, such as weekly use or use after sex and menses.

Vaginal yeast and bacterial infections such as Bacterial Vaginosis. Yeast infections cause intense itching, burning, swelling, and pain while bacterial infections cause a discharge with an odor, irritation, or minor itch.

1. Cooling the Infection: The device effectively cools the infected area to under 86 degrees, causing the infectious fungi (yeast infection) or bacteria (BV) to revert to their dormant state. This reversion is crucial in halting the progression of the infection. 2. Reducing Inflammation: Cooling is a well-established method for reducing inflammation and alleviating symptoms like itching, burning, and swelling. 3. Promoting Good Bacteria: The device may help in fostering the growth of lactobacillus, the beneficial bacteria in the vagina, by creating a conducive cold environment. 4. Breaking Biofilms: The device can disrupt biofilms, a significant factor in infection recurrence, through cooling, pH normalization, and the gentle action of insertion.

Drugs have side effects, adverse reactions, drug-drug interactions, delayed symptom relief, and contribute to drug resistance, which is why drugs are becoming less and less effective.

Preliminary evidence supports that it can clinically cure both Vulvovaginal Candidiasis (VVC) and Bacterial Vaginosis (BV) with the same usage pattern, which is usually 2 times per day for 2 days.

The Vlisse device takes care of symptoms immediately and has no adverse effect on the normal microbiome of the vagina. This contributes to a higher cure rate compared to drugs that do not help the symptoms for days. Anecdotally, we think two uses over 12-24 hour is sufficient based on user experiences. The device offers lasting effect unless the women is exposed to another triggering event such as excess heat, excess moisture, sex, antibiotic exposure, and pregnancy.

Drugs only target ONE specific aspect of the infection (the yeast or bacteria) leading to high failure rates (only 30-70% effective). This leads to reinfections and and drug resistance problems which are deadly to people with suppressed immune systems. Our device targets FOUR aspects of the infection such as the yeast and bacteria, the inflammation, pH, and biofilms.

Clinical trials have shown promising results, with a greater than 90% cure rate in some studies using the device twice a day for two to three days. This high efficacy rate, coupled with the simplicity of use, positions Vlisse as a highly effective alternative to traditional treatments, which can be costlier, less effective, and contribute to rising antibiotic resistance rates in bacteria. Learn more: American Journal of Obstetrics & Gynecology. Pilot Case Series of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis.(https://www.ajog.org/article/S0002-9378(24)00955-4/fulltext) The Journal of Infectious Disease. Use of Intravaginal Cooling to Provide Symptom Relief in Women With Vulvovaginal Candidiasis and Reduce Immunopathology in an Accompanying Mouse Model(https://academic.oup.com/jid/article/231/4/e813/7953302?login=false)