Medicare covers at-home female incontinence treatment

Medicare is now covering Elitone, a surface-applied electrical muscle stimulation device for female stress urinary incontinence that patients self-administer at home.1

Elitone is FDA-cleared. Clinical trial data for the device have shown that Elitone led to a clinically significant (P <.001) 75% reduction in incontinence episode frequency.2 In the study, use of the device was also associated with an 85% reduction in pad usage and a 67% improvement in quality-of-life measures (P <.001 for both).

"After years or decades of bladder leaks, women often give up hope and resign themselves to living less active and less social lives," Gloria Kolb, CEO of Elidah, the developer of Elitone, stated in a press release. "We want women to be aware that products like Elitone can significantly reduce these leaks and improve quality of life, even if they've been incontinent for decades."

Elitone consists of a gel pad with conductive gels that perform Kegel pelvic floor exercise by transmitting low-frequency pulses which contract pelvic floor muscles. This process strengthens the muscles to give them the capacity to stop urine leaks. The pads are external and do not require the use of a vaginal probe. When using the device, the patient can be fully dressed and active. The pads are reusable (maximum 3 uses) and disposable.

The pivotal clinical study of Elitone evaluated the safety and efficacy of the device in 20 female patients with mild/moderate stress urinary incontinence. The patients self-administered treatments at 20 minutes daily for 6 weeks. Incontinence episodes and absorbent pad use were recorded by patients in a daily log. Quality of life, participant satisfaction, and product usability were evaluated through pre- and poststudy questionnaires.

In their study conclusion, the authors wrote, “Participants receiving treatment with the conservative, noninvasive Elitone device achieved meaningful improvement in incontinence symptoms across multiple, patient-centric outcome measures. The degree of improvement aligned with historical performance of more invasive, intravaginal therapies. The therapy may particularly benefit those women who oppose use of vaginally inserted devices. Further, although this study evaluated efficacy as a stand-alone, at-home treatment, physical therapists may realize additional benefits by using the device as an at-home complement to in-office therapy sessions.”

References

1. ELITONE® At-Home Incontinence Treatment Covered by Medicare Insurance. Published online June 15, 2021. Accessed June 15, 2021. https://prn.to/3iI64gE.

2.Kolb G, Kolb E; Richmond C, Hanson C. Surface-applied electrical muscle stimulation for self-administered treatment of female stress urinary incontinence. J Womens Health Phys Therap. 2019;43(4):188-193. doi: 10.1097/JWH.0000000000000147