Monday, April 25, 2022

MedTech Review: ELITONE® - Urinary Incontinence Device

PROFESSIONAL EVALUATION OF A URINARY INCONTINENCE DEVICE

By: Dr Roberta Kline (OBGYN)

BACKGROUND
Urinary incontinence is a common problem for women, affecting up to 1 in 3 women over their lifetime. Many treatments have been devised that have varying degrees of invasiveness and effectiveness, with the most utilized approaches including pelvic floor muscle exercises (Kegel’s), surgery and medication. 

Pelvic floor muscle exercises are typically the first-line approach Stress Urinary Incontinence, and while they can often be effective, many women do not know how to do them correctly. This can lead to lack of improvement or potentially create other pelvic floor issues. While pelvic floor muscle exercises can also be helpful for women with Urge Incontinence, they are often are directed toward lifestyle changes and medication. One of the biggest challenges is that many women suffer from both conditions and finding a solution that is effective for both is often elusive. 

But even if a therapy may be effective, there are two large barriers that must be overcome: access to treatment, and then adherence to that treatment. Even if a woman is one of the fewer than 50% that actually seek medical care and get an effective treatment, adherence is often a key reason why it fails to deliver significant or lasting results. Attempts to address these issues are behind the continued innovation in finding effective treatments that are effective, easy to use, and widely accessible.

Electrostimulation of the pelvic floor muscles for treating Urinary Incontinence is not new (Yamanishi et al), but until recently most approaches relied on intravaginal placement of devices. While these have been shown to have good success, utilization rates are typically low due to the invasive nature and inconvenience of such treatments. (Fürst, MCB et al.) For this reason, less invasive ways to deliver electrostimulation technology have been growing in popularity and have been shown to be effective for both types of Urinary Incontinence (Stewart F, Gameiro O et al. and Stewart F, Berghmans B et al.)

Transperineal electrical muscle stimulation (TEMS) is a relatively new and innovative approach utilizing a noninvasive method to treat Urinary Incontinence. With TEMS, electrodes are placed strategically on the perineum so that pelvic floor muscles are stimulated to contract. While more studies need to be done, early clinical research is demonstrating effectiveness (Kim et al,). 

CLINICAL STUDY OF THE ELITONE
In a cohort study published in 2019 (Kolb et al), they found that the women with mild to moderate stress urinary incontinence experienced statistically significant improved symptoms and quality of life scores over only 6 weeks of using the Elitone device. 

I was able to test out and evaluate the Elitone device, which seeks to reduce the disparity in access to effective treatment utilizing this TEMS technology. This is a self-administered device that contains the electrodes in a gel pad that is placed on the perineum, and utilizes electrostimulation to achieve effective contraction of the pelvic floor muscles. The device is easy to use, and the gel pad provides enough adherence without causing discomfort to the skin upon removal. 

As was described in the patient instructions, the TEMS creates a tingling on the skin that can be a little intense at first, but quickly decreases as the nerve fibers in the skin become desensitized. I found the strength of pelvic floor muscle contraction to be quite adequate and not at all uncomfortable, even at high intensity. While the device is designed so that it can be worn during normal activity, I did find that sitting increased the level of contact with the perineum and seemed to increase effectiveness.

As an ObGyn physician, I know that all women with Urinary Incontinence are not alike. They have varying degrees of pelvic muscle floor tone or strength. It’s important to be able to customize the strength of contraction when being stimulated with a TEMS device. Contractions that are too weak for a woman with fairly good pelvic floor muscle tone may be far too strong for one whose pelvic floor muscle tone is much less. This can lead to ineffectiveness on the one end of the spectrum, and pain on the other. Both will lead to lack of the desired outcome of reducing or eliminating the urinary incontinence. 

One of the big benefits is the ability to control the strength of pelvic floor muscle contraction. The device enables easy modulation of the strength of the electrostimulation, thereby enabling a great level of customization for varying degrees of pelvic floor contraction. Over the course of the treatment, each woman can start at the appropriate strength for her, and then gradually increase over time to achieve the level of pelvic floor muscle stimulation needed to maximize strength and thus outcomes. In addition to the impact on pelvic floor muscles, the Elitone device also provides stimulation to the bladder detrusor muscle as a way to address urge urinary incontinence as well – a big plus for the large percentage of women that suffer from both stress and urge symptoms if future studies confirm the effectiveness of this approach.



CONTRIBUTORS

BOBBI KLINE, MD 
(Educational Dir. /Women's Diagnostic Group)
Dr. Kline is a board-certified ObGyn physician, Integrative Personalized Medicine expert, consultant, author, and educator whose mission is to change how we approach health and deliver healthcare. She helped to create the Integrative & Functional Medicine program for a family practice residency, has consulted with Sodexo to implement the first personalized nutrition menu for healthcare facilities, and serves as Education Director for several organizations including the Women’s Diagnostic Health Network, Mommies on a Mission. Learn more at https://bobbiklinemd.com 


References

1) Electrical stimulation with non-implanted devices for stress urinary incontinence in women

2) Fiona Stewart, Bary Berghmans, Kari Bø, Cathryn Ma Glazener Cochrane Database Syst Rev. 2017 Dec 22

3) Stewart F, Gameiro O et al. Electrical stimulation with non‐implanted electrodes for overactive bladder in adults. Cochrane Database of Syst Rev 2021 Dec 9

4) Kim HW et al. Effectiveness of transperineal pelvic floor electrical stimulation system in improving female stress urinary incontinence: a prospective pilot study. Journal of Inclusion Phenomena and Macrocyclic Chemistry volume 101, pages329–336 2021

5) Fürst, MCB et al. Long-term results of a clinical trial comparing isolated vaginal stimulation with combined treatment for women with stress incontinence. Einstein (Sao Paulo). 2014 Apr-Jun; 12(2): 168–174

6) Yamanishi T, Yasuda K. Electrical stimulation for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9(5):281-90.

7) Kolb G et al. Surface-Applied Electrical Muscle Stimulation for Self-administered Treatment of Female Stress Urinary Incontinence. Journal of Women's Health Physical Therapy: October/December 2019 - Volume 43 - Issue 4

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MedTech Review: ELITONE® - Urinary Incontinence Device

PROFESSIONAL EVALUATION OF A URINARY INCONTINENCE DEVICE By: Dr Roberta Kline (OBGYN) BACKGROUND Urinary incontinence is a common problem f...