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.

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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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Smart Sense: Managing Pain Holistically

INTRODUCTION:

Thanks in part to the web-driven information age, today's educated consumer holds the advantage of some of the fastest research technologies and complete global access to the vast majority of health protocols and treatment modalities available.  This forged our personalized culture where optimal info access and the freedom to decide between many diagnostic and therapeutic principles helps us go beyond the TRADITIONAL (or conventional) medicine.  The Integrative Pain Healers Alliance (IPHA) is committed to exploring all areas of health from current experts, researchers and educators.  We start our report with a popular injury called Plantar Fasciitis. We are fortunate to encounter a specialist in HOLISTIC PODIATRY to shed light on a whole-body approach to healing this commonly painful disorder. Dr. Robert Kornfeld offers his successful strategy to fulfilling what many would consider a 'healthier and more intelligent way' to therapy by combining convention with complementary and alternative medicine.

ADDRESSING PLANTAR FASCIITIS HOLISTICALLY

 Written by: DR.ROBERT KORNFELD (Founder at Chronic Foot Pain Center)

When considering any inflammatory pathology like plantar fasciitis, it is important to not only look at the tissues in pain and make a diagnosis, but it is equally important to understand the mechanisms behind the pathology. In so doing, we need to understand our patient as a unique being and not fall into the trap of treating every patient with plantar fasciitis in the same way. Many patients can develop plantar fasciitis but can have completely different mechanisms that make it difficult for the immune system to heal the injured tissue.

In my world, the world of functional medicine, we need to examine 2 issues before we get into healing the plantar fascia. Number one is we must look at the patient’s BIOMECHANICS, i.e., the structural and functional contributions to the problem. This may be congenital structural issues or problems with the functional aspects of walking and running. It can be poor training, over-training, tight muscles due to lack of stretching, improper footgear for that particular patient’s needs or the necessity to manage these issues with a prescribed, custom molded orthotic device.

Many patients will heal by correcting these biomechanical contributors to the dysfunction which cause the injury to the plantar fascia. But many will not. In those patient’s it become necessary to look at the immune system which is tasked with the job of repairing injured cells. So the second thing we turn our attention to is to discover what burdens there are on the immune system that are making it inefficient and not enabling the healing of the injury. For that, we need to take a patient-specific approach to the epigenetics (diet, lifestyle and environmental issues). The most common things we look for are:

- Poor nutrition/food quality

- Lack of adequate hydration

- Adrenal stress/Neurotransmitter imbalances

- Detoxification disorders

- Hormonal changes

In addition, we must look at what is involved in healing. The plantar fascia, being a connective tissue, receives its blood flow through microscopic blood vessels, not large arteries. In our modern society, we are dealing with many chronic stressors that can lead to adrenal/neurotransmitter imbalance. If there is an excitatory neurotransmitter dominance, we see microscopic blood vessels go into spasm. This is a primitive survival mechanism designed to shunt blood from the extremities and send it to the heart for increased blood flow to the upper arms and legs to either fight the beast that wants to eat us or run away from it. Correcting these chemical imbalances can alter the rate of perfusion into these tiny vessels in order to deliver the necessary substrates of healing.  

HEALING THE PLANTAR FASCIA

Once all of these mechanisms have been diagnosed and addressed (obviously in patients who do not respond to conventional treatments), then we can begin to foster the healing of the tissues. I utilize regenerative medicine which are medicines that stimulate more efficient repair and message the immune system to release protection and open the pathways that can repair the injured cells. This is health promoting instead of using drugs with side effects that interfere with normal physiology.

To that end, I use homeopathic injections, prolotherapy, PRP or amniotic allograft injections. There are different reasons why I choose different approaches but it is all patient-specific. Regardless of the chosen therapy, they are all designed to get the immune activity focused on healing and repair and not on protection. In this way we heal patients AND we leave then healthier than when they first came to see us.

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CONTRIBUTOR:

DR. ROBERT KORNFELD has been practicing podiatric medicine and surgery for over 40 years. After training in traditional medicine and surgery, Dr. Kornfeld sought to answer a very important question - why does this specific patient have this diagnosis? He knew that finding the underlying mechanism to the presenting pathology was the critical issue that traditional medicine was not addressing. This naturally brought him into the field of holistic medicine. His dedication to treating chronic foot and ankle pain at its source has given him well-researched insight into how the human body manages cellular injury that it is unable to repair so he can alleviate chronic pain syndromes that have resisted traditional medical approaches. Dr. Kornfeld has offices in New York City and Port Washington, Long Island. (https://www.drrobertkornfeld.com/)

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HOW PAIN LOOKS LIKE- QUANTITATIVELY 

By: Dr. Robert L. Bard

The research benefits of using ultrasound scanning in therapeutic monitoring allows for tremendous flexibility in exploratory detection. Once we have established the initial Base Line of the ‘before and after’ scan, having probe in hand empowers the diagnostician to go deeper and wider- allowing for more answers and possibly finding other pathologies.   After we looked at the obvious muscle abnormality, the question is to go back and see what's causing the problem. Upon observing what’s under the white skin area, there appears a very thick white band (FASCIA covering the muscle) between the two dark layers of the subcutaneous fat and the muscle.  We notice that the fascia splits into two levels with the upper arrows, denoting the top part of the split and the lower arrows showing the bottom part of the split. The black area in the split is filled with fluid indicating the fascia lining is abnormal and this is a way that we can follow the cause for the muscle irritation in future tracking.  (see complete article & video)

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PAIN 101: PLANTAR FASCIITIS BREAKDOWN 
by: Josh Tiberius Schueller, PT

Plantar Fasciitis is a challenging, difficult and often time frustrating injury that effects millions of people per year. PF is not considered a serious injury on the spectrum of musculoskeletal injuries so there have been a lack of attention to effective treatments. Many suffers are active competitive people who struggle with the lack of effective treatment. These people have to take weeks into months off from training because of this injury. Traditional treatments have been lackluster in results which has spawned “gimmicky” devices that have flooded the market. The need for a safe, effective treatment for PF is apparent. These devices need to be validated to decrease consumer fraud. The health care professionals need to realize that traditional treatments of ice, rest, and immobilizing are not effective for active people. (see full article)

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