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Understanding and defining your incontinence

What do we mean when we talk about incontinence?

A healthy and functioning bladder is supposed to store urine until you want to empty it, if you suffer from urinary incontinence, you’ll leak urine without intending to.

Urinary incontinence might not be life threatening, but it affects quality of life and can lead to real embarrassment.

If you’re wondering, “Why me?” The reality is urinary incontinence can happen to anyone, at any age, although it is most commonly reported in older people and women. To put it in perspective, over 12 million Americans suffer from urinary incontinence, and about one in every three people above the age of 60 is incontinent.

If you have become incontinent, it doesn’t necessarily mean you’ll always suffer from incontinence. Some incontinence, known as transient incontinence, can be short term. It tends to occur in older people and may be caused by mental confusion, infection, medications, depression, immobility, constipation, among other reasons.

Whether this is a new situation for you, or if you’ve been suffering in silence for a while, for your bladder to function normally, you need to have an intact neurological system, urinary system and competent sphincters.

So, what does this all mean?

A normal nervous system allows your bladder to fill and empty in a normal way, without spilling over. The brain receives signals from the nervous system, which indicate when the bladder is full and when it needs to be emptied.

However, certain neurological conditions may have an impact on your bladder. So the first step is to identify if there are any neurological issues that may be contributing to your bladder-control problems.

The second system that needs to be working is your urinary system. The urine needs to come into the bladder, and it needs to be able to empty out of the bladder. So the urinary system cannot have any blockages in it, which would impede the urine from coming into the bladder and emptying out of it.

The third thing you need is to have competent sphincters.

What’s a sphincter? A sphincter is like a door. You want the door to stay closed at the base of your bladder when you want the urine to stay in your bladder. And you want the door to open when you’re ready for the bladder to empty. This sphincter needs to have the strength to stay shut, but it also needs to have the neurological function to know when to be closed and when to open.

Now that you understand this, let’s talk about the five basic types of established incontinence.

  1. Stress Incontinence: Stress incontinence is caused by a weakness of the bladder’s muscles. Stress incontinence occurs most frequently in women and is thought to be due to pelvic relaxation of tissues from childbirth or aging. Stress incontinence is often worse when a person is overweight. Sufferers experience incontinent episodes in the course of exercise, coughing, sneezing, laughing, or any body movement that puts pressure on the bladder..
  2. Urge Incontinenc:. Urinary urgency is a recurring need to urgently go to the bathroom. . It can often be described as a desperate need to go to the bathroom and in some cases the need to urinate cannot be controlled and leads to incontinent episodes. Some people may experience symptoms of both stress and urge incontinence.
  3. Overflow Incontinence: This may occur when a person cannot completely empty their bladder, causing the bladder to become overfilled and leak. Prostate enlargement in men may cause this type of incontinence.
  4. Functional incontinence: A physical or mental impairment keeps you from making it to the toilet in time. For example, if you have severe arthritis, you may not be able to unbutton your pants quickly enough.
  5. Mixed incontinence: You experience more than one type of urinary incontinence.

This may sound like a lot of information to process and be pretty overwhelming, but the good news is that about 80% of people with incontinence can be helped or cured. Understanding what kind of incontinence you are suffering is the first step in combating it. The more you understand, the more information you have about your condition, the better equipped you are to fight it.

The Zida program is a unique and one of a kind treatment that combines the transcutaneous neuromodulation treatment delivered by using the Zida Control Sock once a week for 30 minutes a week, along with the accompanying behavioral/ educational treatment.

We are here to make sure you receive all of the information, tools and help you need to conquer your incontinence in a non-invasive, non-drug, non-surgical at home FDA approved solution to treat the root of your incontinence.

The Zida Control Sock

Zida’s non-invasive neuromodulation Control Sock is a prescription medical device designed for patients’ self-administered home use. It is easy to use and does not require specialist training. The Zida Control Sock can either be used as a stand-alone treatment option or in conjunction with standard first- and second-line therapies.

The FDA-cleared Zida Control Sock delivers the same effective neuromodulation treatment as percutaneous tibial nerve stimulation devices (Urgent PC/Laborie, Nuro/Medtronic) from the comfort of patients’ homes.

The patented Zida Control Sock delivers transcutaneous stimulation via seamlessly knit electrodes into a cotton sock. The sock ensures the correct placement of the active embedded electrodes to stimulate the tibial nerve. Zida’s ability to consistently provide proper electrode placement and its decades of textile experience are core competencies of the Zida team. Our intimate knowledge of textile industry standards, such as those developed by the American Association of Textile Chemists and Colorists (AATC) and the Sock Testing Hosiery Consortium, is the core of our trade secrets.

The Zida Control Sock has two parts

The Control Unit is a small key fob-sized device that weighs 20 grams and measures 2” x 1.5”. It attaches simply and seamlessly to the ZIDA sock using two magnetic snaps. The Control Unit uses an AAA battery that will last for the initial 12-week recommended treatment course. The control unit has three buttons, On/Off and increase and decrease, which affect the intensity of the stimulation. The control unit was designed using UI principles appropriate for the 55+ market. To that end, the device is stand-alone and does not require a Wi-Fi or Bluetooth connection with a smartphone. It uses a power source that patients are comfortable with and can change easily and conveniently.

The Zida Control Sock is a cotton blend sock with electronics and electrodes embedded. The sock comes in 4 sizes: Small, Medium, Large, and Extra-Large. Patients choose their shoe size, and the current sock sizing regime ensures that 95% of the US population can wear the Zida Control Sock while ensuring exact electrode placement.

Clinical Experience Summary

Two consecutive randomized, double-blind trials were conducted in the United States at a single center. The first study was closed after 23 out of 50 planned subjects prior to COVID-19 enrollment issues. Subsequently, a second trial was launched, enrolling 40 subjects. In total, 63 subjects, 23 in the first and 40 in the second trials, were randomized and treated.

The primary objective of both studies was to evaluate the efficacy and safety of the ZIDA device in treating overactive bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. Subjects diagnosed with OAB with clinically acceptable laboratory results who completed a baseline 6-day bladder diary, scored 60 or higher on the quality of life measure used in the study, and did not meet any exclusion criteria were eligible for the study.

Subjects were randomized to the ZIDA device or a sham control in a 1:1 ratio blinded to the treatment they received. The principal investigator, the treating physician, the subject, and the sponsor were blinded as well. Subject assessment of the treatment arm both after the first week of treatment and at the end of the second study demonstrated that subjects were effectively blinded since similar proportions of subjects assessed that they were receiving the ZIDA device in both treatment arms.

In both studies, the majority of subjects were female (70% first study; 80% second study), and the mean age was 68 years (range: 52, 85) in the second study and 67 years (range: 45, 82) in the first study. In the first study, 61% of the subjects were Hispanic, 4% were African American, and 35% were Caucasian. In the second study, 10% were Hispanic, and 90% were Caucasian.

Effectiveness:
In the second study, treatment success was defined as at least a 50% reduction in urinary urgency voids with or without incontinence or at least a 30% reduction in the frequency of daytime or nighttime voids from baseline to week 12. The treatment success rate in the ZIDA device arm was 80%, significantly larger than the treatment success rate of 39% in the sham control arm (p=0.02). Hence, the primary endpoint of the study was met. As presented in the table, subjects on the ZIDA device had a significantly larger decrease in the number of urgent episodes from baseline to Week 12 compared to subjects on sham control (p=0.03), a significantly larger reduction in the number of incontinence episodes from baseline to Week 12 compared to sham control (p=0.004), and a larger decrease in the total number of voids per day from baseline to Week 12 compared to sham control (p=0.06). In the first study, the subjects did not complete a bladder diary, so this information was unavailable.
In both the first and second studies, quality of life was significantly improved from baseline to Week 12 in subjects on the ZIDA device compared to those on the sham control as measured by the OAB. Hence, the key secondary endpoint in the second study and the primary endpoint of the first study were met.
When combining the subjects from both studies, the change in the quality of life from baseline to Week 12 was similar in each treatment arm for Caucasian and Hispanic subjects. Quality of life was significantly improved in Caucasian and Hispanic subjects from baseline to Week 12 in subjects on the ZIDA device compared to those on the sham control as measured by the OAB-q SF. Therefore, the results of this study can be generalized to both Caucasian and Hispanic individuals.
In summary, the ZIDA device is safe and effective in reducing urinary incontinence, urinary urgency, and total urinary frequency of daytime and nighttime voids and improving the quality of life for subjects with overactive bladder. The ZIDA device was self-administered by the subject at home and was reported to be easy to use with 100% treatment compliance for 12 weeks.

Neurostimulation, a form of therapy in which a low-voltage electrical current is used to treat medical conditions affecting parts of the nervous system, has grown dramatically in recent years. According to Medtech Insight, the market for neurostimulation devices in the U.S. alone is expected to grow from approximately $2.5 billion in 2018 to approximately $4.5 billion in 2023. FDA-approved neurostimulation devices are currently utilized to treat a range of indications, including voiding dysfunctions, chronic pain, epilepsy, essential tremor, Parkinson’s disease, hearing loss, and depression. These devices are implanted in the body or used non-invasively to stimulate different parts of the nervous system, including the spinal cord, sacral nerves, and vagus nerve, among other areas. The neurostimulation market represents a significant opportunity for us in the treatment of urinary symptoms often associated with incontinence.
Voiding dysfunctions affect urinary or fecal control and can result in uncontrolled bladder sensations (overactive bladder) or unwanted leakage (urinary or fecal incontinence). OAB is a prevalent and challenging urologic problem affecting an estimated 50 million Americans. In 1996, the Agency for Health Care Policy and Research (AHCPR), a division of the Public Health Service, U.S. Department of Health and Human Services, estimated that urinary incontinence affected about 13 million people in the United States, of which 85% (11 million) were women. AHCPR estimated the total cost of treating incontinence (management and curative approaches) in the United States to be $16 billion. The number of individuals developing voiding dysfunctions will increase as the population ages and as life
expectancy continues to rise.

When patients seek treatment, physicians generally assess the severity of the symptoms as mild, moderate, or severe. However, regardless of the severity, patients will often consider drug therapy and minimally invasive treatment first.

The Zida Control Sock offers home-based, minimally invasive treatment solutions which have no side-effects and no negative drug interactions.

Existing treatment solutions can be broken down into two general categories:

The first category includes the devices that use neuromodulation, thus focusing on the nervous system, such as the Urgent PC, Nuro, Interstim, and Axonics devices. These solutions are proven to work for both men and women.

The second category of solutions on the market today does not focus on the nervous system but rather the muscles, specifically, the muscles in the pelvic floor. This muscle approach is something used for women only. A recent market entry includes the Innovo device, a pelvic floor trainer for home use. This device is designed for Stress Incontinence and works only for women.

Zida’s non-invasive therapy option is easy to use and does not require specialist training. Similarly, Zida provides a new option for general practitioners to achieve meaningful results for their patients. The Zida device can either be used as a stand-alone treatment option or in conjunction with standard first- and second-line therapies.

COMMERCIAL INSURANCE ORDER PROCESS

Tactile Medical employs an experienced team of reimbursement professionals committed to helping you and your patients navigate the insurance process, working with all stakeholders to obtain medically necessary devices for your patients in an efficient and timely manner.

Commercial insurance coverage varies depending upon the individual health plan medical policy. Tactile Medical will be happy to provide you with more specific information about your patient’s commercial insurance coverage. Contact us with any questions you may have.

CLINICIAN ADVOCACY
Tactile Medical partners with clinicians and patients to advocate for enhanced coverage, network inclusion, and improvements in complex medical policies. If you are interested in becoming a voice for access to care, please complete this form with your contact information.
MEDICARE ORDER PROCESS

To initiate a Medicare order for a product to treat lymphedema or venous leg ulcers, fax a copy of the patient’s medical record face sheet to Tactile Medical at 1.866.435.3949.

After we have verified that Medicare is the patient’s primary insurance, a Medicare Specialist will work with you to determine the appropriate pneumatic compression device for your patient, based upon medical documentation. We will provide guidance on required forms and documentation. Click here for guidance on required forms and documentation or call the Medicare hotline at 855.319.9949.

USE INSTRUCTIONS

Use only once weekly for the recommended 30 minutes treatment session. More frequent use of ZIDA or longer treatment times have not been clinically evaluated. Overuse may result in medical complications. For more use instructions see User Guide.

ZIDA CONTROL UNIT

1. Electrical Current Settings:

» Pulse characteristics:
– Fixed pulse frequency of 20 Hz.
– Pulse width of 200 microseconds.
– Square waveform.
» Resistance of 500-4000 Ohms.
» Ten incremental presses on the current adjustment buttons increases/ decreases the stimulation level by 1 mA (R.M.S).
» Continuously pressing on the current adjustment buttons increases/ decreases the stimulation level by 1 mA/Sec (R.M.S)

2. Washing & Care Instructions

» Machine wash with like colors in cold water on a delicate cycle. Use mild detergent
» No Bleach or Fabric Softner
» Hang & Dry Sock. Do not tumble dry
» Do not iron
» Do not dry clean
» The Zida Control Sock has a lifespan of maximum 30 washes. After 30 washes, sock should be replaced

CONTRAINDICATIONS

1.Use of the device is contraindicated for use on patients with
the following medical history or conditions:

» Patients with pacemakers or implanted defibrillators
» Patients prone to excessive bleeding
» Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function
» Patients who are pregnant or planning to become pregnant while using this product.

2.The CONTROL UNIT is not intended for intra-cardiac or trans-thoracic use.

3.Concurrent use of medical monitoring equipment during stimulation is not recommended.

4.This device is not suitable for use around flammable compressed mixtures including but not limited to oxygen or nitrous oxide.

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