ELITONE, an external pelvic floor exerciser, generated excitement at CES 2022 earlier this month. Developed by femtech innovator Elidah, ELITONE is CE-marked and FDA-cleared as a non-surgical, non-invasive treatment for stress urinary incontinence, or bladder leaks. ELITONE is a paper-thin, discrete GelPad that women can wear comfortably as they go about the day. That’s a major advantage over internal pelvic exercise devices, which require privacy and dedicated time away from other activities to achieve results.
The buzz around ELITONE makes sense, considering pelvic floor disorders affect about one-third of all U.S. women and roughly 50% of women over the age of 55. Pregnancy, childbirth, and aging lead to weakened or damaged pelvic muscles and connective tissue, resulting in pelvic floor dysfunction that interferes with urination and bowel function.
Embarrassing symptoms such as bladder and bowel leakage, as well as pain during urination or sexual intercourse, can complicate daily life. Pelvic floor disorders often stop women from participating in recreational activities and intimacy, affecting their overall quality of life. Providers typically advise women with urinary and urge incontinence to practice Kegel exercises regularly. Kegels strengthen the muscles around the rectum, bladder, and uterus, reducing leaks and urge frequency.
Unfortunately, learning to perform these exercises effectively can be challenging. Some devices help women perform the exercises when inserted in the vagina; they stimulate pelvic muscle contractions with transcutaneous electrical nerve stimulation (TENS). But many women don’t have access to a private space or enough time to lay down and use an internal device for 30 minutes every day.
When exercise hasn’t helped, urinary incontinence is usually treated with surgery, even though an invasive procedure isn’t always medically justified for mild to moderate cases. ELITONE was designed to fill this gap in treatment options with an affordable, non-invasive solution. In contrast to internal devices, which contract the entire pelvic floor, ELITONE only targets the muscles surrounding the urethra to address urinary incontinence and urge incontinence specifically.
The ELITONE starter kit includes two GelPads and a tiny, lightweight controller featuring simple on and off buttons. The GelPad, reusable up to three times, is worn inside the underwear to fit snuggly against the pubic bone. Soft, conductive hydrogels borrowed from the wound care industry coat each pad, ensuring that they feel comfortable and won’t tug on pubic hair. A flexible cord connects the pad to the controller, which can clip to clothing or fit inside a pocket.
During treatment, electrical muscle stimulation (EMS or e-stim) causes the pelvic floor muscles to contract and release 100 times per 20-minute session. ELITONE produces more prolonged and robust contractions than women can do independently. Initial treatment for urinary incontinence consists of four sessions weekly for 6-10 weeks. As the pelvic muscles strengthen and bladder control improves, the need to wear bulky absorbent pads for protection decreases. After the initial period, maintenance treatments keep those muscles toned so women can feel confident during daily life and participate in their favorite physical activities without worrying about embarrassing accidents.
In a clinical trial, 75% of participants experienced a significant reduction in urinary leaks after using ELITONE for six weeks, and 85% reported the treatment improved their quality of life. According to a press release for CES, another study recorded fewer leaks in 95% of participants, while 85% decreased their use of absorbent pads.
Elidah continues to study ELITONE’s effect on urge incontinence, and a version for men is already in development.
Available on the website and at CVS, ELITONE is FSA and HSA approved and covered under Medicare. Monthly payment options are also available. The ELITONE Starter Kit costs $399, and the ELITONE Bundle, which includes the device and 6 GelPad packs, is priced at $503. Elidah hopes the over-the-counter device will also become authorized for prescriptions, thus making ELITONE available to help a broad, diverse population of women. Now that’s definitely something to get excited about.