Elitone is a perineal-applied, neuromuscular stimulation device, FDA-cleared to treat women with stress and urge urinary incontinence. It is available over-the-counter, but receiving an Rx can help patients obtain coverage.
Behavioral therapies require patient consistency and time, while in-office treatments often face low compliance due to scheduling, cost, and invasiveness. These limitations can leave many patients underserved and still symptomatic.
25% of women perform Kegels incorrectly. And most don’t do them often enough to achieve benefits.
Only 13% of PT referrals will complete treatment.
Side effects, cost, and waning efficacy after 4-6 months
Elitone delivers neuromuscular stimulation through a patented GelPad, allowing patients to receive treatment during daily activities. Clinical studies show high compliance and symptom improvement, even in patients who previously failed other therapies.
External Design
Perineal Placement:The patented, one-size-fits-all shape promotes correct anatomic positioning while achieving a high level of comfort, whether sitting, standing, or walking.
Intuitive Interface: Simple interface promotes safe and repeatable at-home use. No programming required.
Four Conductive Regions: Spacing of the conductive regions targets key pelvic floor muscles used to achieve continence.
Low-Tack Hydrogel: The GelPad’s hydrogel was selected for its low tack and high conductance. This material has undergone ISO 10993 biocompatibility testing and is ideal for use on sensitive skin and over hair.
Targeted Waveform
Pre-Modulated Waveform (PMW): The nervous system doesn’t perceive frequencies > 1000Hz. Elitone uses continuous amplitude modulation at 2000Hz (carrier wave) to minimize surface sensation while delivering current to maximize bioavailability and stimulate the underlying pelvic floor muscles. The symmetric profile of this PMW technology also enhances GelPad longevity and is safer for skin contact.
Toning Wave + Calming Wave: The output combines two stimulation frequencies, 4 seconds at 50Hz to activate muscle contraction, followed by 2 seconds at 10Hz to calm the muscles and surrounding tissues. Then the body is allowed to rest for 6 seconds, after which the cycle repeats. These stimulation frequencies have a long history of use for successfully treating stress, urge, and mixed urinary incontinence.
Clinical Data
Case Series – Significant Leak Reduction: 20 Subjects, who had been incontinent for an average of 10 years, treated with Elitone for 6 weeks. They maintained leak diaries and completed quality-of-life assessments (I-QoL). [READ ABSTRACT]
• 95% had reduced leaks
• 75% had clinically significant reduced leaks (> 50%)
• 71% average reduction in leaks
• I-QoL improved by 14.6 pts (>2.5 pt is clinically significant)
• 67% reduced pad use, clinically significantly (>50%)
Ultrasound Visualization – Measurable Pelvic Floor Contraction: Subjects self-applied the Elitone device. Transabdominal ultrasound images were obtained of the bladder and pelvic floor under Elitone stimulation, while performing a Kegel contraction, and while doing both simultaneously. Image analysis revealed that with Elitone the pelvic floor moved with a similar direction and magnitude to correctly performed Kegels. Further, a subject with no measurable pelvic floor movement with an attempted Kegel, achieved desirable movement with Elitone. [READ ABSTRACT]
Randomized Controlled Trial – Significant Difference from Sham: 48 Subjects self-administered 12 weeks of treatment with either the Elitone device or a sham device. Baseline characteristics were established for leaks/day, pad use, incontinence related quality of life (I-QoL), and a 24-hour pad weight test. Post-study results were compared to baseline considering absolute change, percent change, and responder rate using recognized thresholds for clinical significance. Leaks reduced by 52.8%, which is notably more than the 31.7% improvement rate from a meta analysis of intravaginal stimulation studies.
Prospective Trial – Urge Incontinence: With the new Elitone URGE device, 32 subjects were randomized between two device configurations. 97% of women improved. 85% of women were responders with over 50% improvement. All 22 questions of the I-Quality of Life tool improved, in total a 26.7 point improvement (10x greater than what FDA considers clinically significant.) Results were presented at the SUFU conference in 2023.
Patient Experience
We love hearing how patients and healthcare providers are benefitting from Elitone.
“I stopped wearing pads completely.” – Gabrielle ★★★★★
“This is brilliant! It is so not invasive, so simple and so comfortable. I’ve tried so many things over the last 15 years. This was the easiest, yet the most productive. I truly love your product.” – Lori ★★★★★
“With a vaginal device, I would have to hide in my bedroom and pray the kids wouldn’t walk in! With Elitone, I can wear it under my clothes and watch a movie. It’s so easy to use! Before Elitone, I struggled to sleep through the night. Now I get more rest.” – Teresa ★★★★★
“When I started Elitone, I couldn’t even feel myself contracting my muscles, that is how lax the muscle tone was. Elitone has “woken up”… the muscles, as well as decreased my need to wear incontinence pads.” – Diane ★★★★★
Elitone requires no capital equipment or in-office time, and patients can start therapy with minimal clinician oversight. It’s an efficient option that improves outcomes without adding workflow burden.
Can I prescribe Elitone?
Absolutely! While a prescription isn’t necessary it may be the best route in some cases. A prescription may help your patients maintain compliance and receive reimbursement. Use this written order to document medically necessary. Patients may also pay with their FSA/HSA accounts. Elitone is covered by Medicare.
Can my patients buy Elitone over the counter?
Yes. Patients can purchase directly from elitone.com. We provide product brochures to help communicate the treatment benefits and have customer care ready to answer their questions. Patients can use their FSA/HSA funds to purchase Elitone. Payments may be broken up into bite-size chunks with our payment plans, equalling the cost of pads/month!
Can I stock and resell Elitone?
Yes! Patients may be more compliant when Elitone is provided directly by their clinician, so many providers buy from us at preferred pricing and resell Elitone at the full retail price. Qualified clinics will have access to demo units, product brochures, and other support materials.
How do I introduce Elitone to my practice?
We would love to work with you. The best way to get started is to call us at 978.435.4324 or email us at clinicians@elitone.com. You can also request an information kit below and we will be in touch within 24 hours with product information and more. We look forward to working with you.
Prescribing Elitone is simple and seamless—we’ve streamlined the process to make it easy for both your office and your patients, with minimal paperwork and maximum support every step of the way.
Complete the Detailed Written Order (DWO) and send it along with a copy of the insurance card to us at FAX: 833-830-1310 or EMAIL: billing@elidah.com
For Original Medicare (Part B) patients, we process the claim directly. For other payers (Medicare Advantage, Medicaid, private payers) we send the prescription to a partner DME for processing.
Once coverage is verified, we send to device directly to the patient. Your office will be notified when the device is shipped so you can follow up with the patient as needed.
Do you still have questions about Elitone? We’re here to help.
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