Jul 7, 2009 (Ft. Lauderdale, Florida)

The aggressive treatment of all forms of severe urinary incontinence (UI) began almost 40 years ago with the introduction of the first bladder-neck suspension (BNS) procedure protocols and the invention of bulking agents (spearheaded by our Company’s esteemed founding Medical Director, Dr. Victor Politano). Prior to that time, UI was considered a nasty inconvenience that did not have much impact on the total healthcare system other than for those who had it, or for those who were responsible for the caretaking of the people who had it.

However, as the human lifespan continued to expand and more factors contributed to more cases of more severe levels of UI, it became apparent that this benign medical condition was becoming more than just a personal disaster, it was becoming a social and healthcare nightmare costing healthcare systems around the world tens of billions of dollars per year (and ever expanding), and tens of millions of patients (and their caretakers) tremendous losses to their quality-of-life (QoL). In fact, uncontrolled, severe UI became the number one cause of all nursing home admissions around the world (accounting for more than half of all such admissions).

It also became apparent UI was not just a condition that simply affected the older generation, but soon became a nightmare for many within the younger generation, as well, whether as a result of birth defects (like Spina Bifida and autism) or spinal cord injuries (wherein severe UI is considered the number one worst side-effect that resulted from the injury) or the onset of a number of different diseases that affected younger sufferers (like multiple sclerosis) or just the act of childbirth for many women.

The first pioneers in the field (like our own Dr. Politano) began conceiving of ways to do the most direct treatment that would moderate and reduce the unwanted and untimely flow of urine, causing a reduction of the size of the urethral canal’s inner diameter, either by compressing or folding the urethra. Dr. Politano conceived of compressing the urethra by injecting bulking agents at the bladder-neck, while others first conceived of creating a fold or “kink” in the urethra by trying to re-support portions of the lower vaginal organ group (after it experienced prolapse) by creating a suture suspension of the tissue (now described by over 200 different protocols, known collectively as bladder-neck suspensions [BNS]). Still another company created the first, and still currently only, artificial sphincter device, which is hydraulically-driven. Another of the treatment products created almost 30 years ago, and two that are still being used today are the neuro-stimulation device (for urge incontinence) and bladder-neck suspension “slings” (a new version of the BNS, that currently uses a variety of different sling materials from synthetics to reprocessed human cadaver tissue). Surprisingly, all of these technologies and protocols are still a major part of the current array of treatments still available, and are still among the primary weapons (some even still considered the “gold standards”) used for the treatment of severe UI.

It has only been within the last ten years that some newer technologies and products have been introduced, primarily the newer mid-urethral sling (AKA; the tension-free vaginal tape – TFVT) and stem cell therapy injections. All of the above treatment products or procedures have been designed to, in some way, compress or narrow the urethral canal’s diameter, with the exception of the neuro-stimulation device, which tries to create better continence by disrupting the inappropriate nerve signals being sent from the brain to the bladder wall that cause urge UI episodes. Even the stem cell therapy injections are trying to compress the urethra by rebuilding the sphincter muscles that control the urethral canal’s closure. Accordingly, there can be little argument that the primary treatment for severe UI is the best possible mode by which the product or treatment could compress the urethra in an effort to control the flow of urine through the urethra.

The diagrams below describe how each of the above treatment products or protocols is designed to compress or fold the urethra (leaving out the neuro-stimulation device, which does not mechanically act on the urethra at all). We also left-out a diagram of how a bladder-neck suspension (BNS) works, but suffice it to say that the BNS attempts to accomplish the same thing done by the sling suspensions, only attempting to support the vaginal prolapse with sutures, not a full sling product.

 

The cases that will be significantly helped by returning to the patient, sufficient lower urinary tract control through stem cell injections that result in the rehabilitation of the urethra sphincter muscle (the percentage of severe cases wherein this can be accomplished is not yet known), the greatest problem for surgeon and patient alike, when attempting to utilize any of the other current severe UI treatments that, in some way, compresses or folds the urethra, is the significant amount of “guesswork” that is involved with such implants or procedures.

The Problems with the Mid-Urethral and Traditional Sling Surgeries:

Too Many Guesses or Biases Affect the Outcome of Each Surgery
Surgeon’s Experience and Skill
Not all surgeons come to each of these surgical procedures with the same levels of experience or the same group of skills, perhaps, two of the major differentiation factors that affect the outcomes of such procedures.

Surgeon’s Bias on the Implant Day
Even the surgeon’s particular abilities might vary from day-to-day.

Thickness of the Urethra
Each person’s urethra may vary in its thickness, which is never measured prior to these types of procedures, although such a measurement may have significant relevance when trying to decide on just how loose or tight the surgeon may want to set the compression level of the specific product being implanted or procedure being done.

Level of UI
There has yet to be any specific, uniform measurement created to describe exactly the level of UI each patient has (between 1% and 100%), therefore making it impossible for every surgeon to ascertain such a measurement, which of course, may have a major bearing on how accurately any of these implants or procedures are being done (especially with regard to the setting of the compression level for each patient).

Anatomy of Patient (Girth, Fatty Tissue, etc.)
Even each patient’s different anatomical structure may require an adjustment of the proposed compression level setting.

Tissue Growth Factor of Patient
Although not mentioned too often, each patient may have different levels of a tissue growth factor, which may have significant relevance to the placement and compression level settings done during each procedure, as the tissue growth that happens post-surgery could significantly disrupt the chosen placement position.

Supine versus Upright Organ Positions – Gravity Is an Issue
Another issue for each surgeon is that these surgical implants or procedures are performed on patients when they are in the supine position (lying down), and the compression level settings are estimated right then and there (and in some cases, such compression level settings require setting the tension level of the product or sutures). The problem is that the patient spends most of her/or his life in the upright position, and all of the patient’s organs and tissue re-align themselves differently in the upright position (in contrast to the supine position), and these re-alignments could vary greatly enough to completely disrupt the compression level settings put in-place during the procedure (when the patient was in the supine position).

Setting Tension (based upon fake cough test)
Ultimately, most of these implant and surgical procedures are finalized based upon a final fake “cough test”, which is supposed to simulate any “real world” experience each patient is likely to encounter with their real UI. We will leave it to the observer as to whether or not this seems to be an adequate measure of a “real world” UI episode.

Decision on Setting Tension (too tight or too loose)
Of course, the above factors contribute to the overall problem of how loose or tight any individual patient’s setting should be. However, and perhaps even more of a factor is that each surgeon, with such incomplete knowledge, has to decide on whether to set the compression level too loose or too tight. As it turns out, there is not much of a decision here, in that, setting the compression level too loose may just result in a less than adequate resolution of the UI, but setting the compression level too tight could easily result in a blockage of the urine flow, potentially putting the patient at risk, including, at risk of death. Accordingly, all of the surgeons that perform all of these implants or procedures, will wisely err on the side of too loose, rather than too tight, which is the reason why eventually so many of these procedures end in significant reductions of any patient-satisfaction-surveys that are done over the longer term.

Slings Create Unnatural Tension (erosion and necrosis threats)
Special attention should be drawn to the mechanism by which how most “sling” surgical-repairs-of-UI function. Slings are literally little “hammocks” threaded around the back of the urethra (mostly at the bladder-neck) and are then sutured or stapled to an anchor position (either the pelvic bone or some other tissue in the area) creating a “kink” in the urethra designed to impede the flow of urine through the urethra. This procedure requires that some level of tension is placed on the back side of the urethra to create the kink. Anytime there is any type of tension exerted on living tissue by any kind of foreign material (whether synthetic or reprocessed human tissue), there always remains the threat that such material will either erode into the tissue or cause necrosis, while also setting up the possibility for additional infection in the area. In some cases, the sling material (more usually associated with the human or animal tissue products) may actually stretch over time, significantly reducing efficacy. These are, of course, four significant problems associated with the use of slings to treat UI.

Tension-Free Tape Completely Surrounds Urethra
In contrast to the slings, the new Tension-Free Tape (TFVT) was designed to avoid the tension issues associated with the slings, in that the TFVT is placed around the urethra (more at the mid-point) with no connection to other tissue required (the TFVT simply surrounds the urethra at its point of contact). However, this does not eliminate the problems associated with the placement of the TFVT. It only exchanges one problem for another, in that although there is no tension to deal with, there is the problem that the TFVT completely surrounds the urethra in what sometimes results in the strangulation of the vessel, again with the complication that might result in either erosion or necrosis.

A Quantum Leap Forward in Severe UI Treatment:

Introducing the new Precision Medical Devices’ (PMD) Flow Control Device (FCD) A Bionic, Remote Telemetrically-controlled Urethra Valve System. How does the PMD-FCD resolve the problems associated with the other products or procedures currently being used to treat severe UI?

Surgeon’s Experience and Skill
Because the implant procedure protocol itself is so easy, and does not require a significant amount of experience or skill, any variations found between each surgeon is minimized, mostly as a result of the product’s design and its on-board remote telemetry control system, which allows each surgeon to make any number of adjustments to the valve’s pressure on the urethra (after surgery), which allows the surgeon to find the optimal setting for each patient (not too tight and not too loose).

Surgeon’s Bias on the Implant Day
For the same reason the surgeon’s particular experience and skill level is minimized by the implant protocol, the surgeons’ day-to-day variation in their abilities is also minimized.

Thickness of the Urethra
As a result of the product’s post-surgery adjustability, any variation in the patients’ urethra thickness becomes moot as the adjustment system can make any appropriate adjustment required by any specific variation presented by each patient.

Level of UI
Again, as a result of the product’s post-surgery adjustability, any variation in the patients’ levels of incontinence becomes moot as the adjustment system can make any appropriate adjustment required by any specific variation presented by each patient (especially with regard to the setting of the compression level for each patient).

Anatomy of Patient (Girth, Fatty Tissue, etc.)
Again, as a result of the product’s post-surgery adjustability, any variation in the patients’ anatomies becomes moot as the adjustment system can make any appropriate adjustment required by any specific variation presented by each patient.

Tissue Growth Factor of Patient
Again, as a result of the product’s post-surgery adjustability, any variation in the patients’ tissue growth factor becomes moot as the adjustment system can make any appropriate adjustment required by any specific variation presented by each patient.

Supine versus Upright Organ Positions – Gravity Is an Issue
Again, as a result of the product’s post-surgery adjustability, the fact that the implant was done in the supine position does not affect the post-surgery adjustment procedure as the adjustments will be made while the patients are in the upright position, such that each physician will be able to “dial in” the optimal setting for each patient.

Setting Tension (based upon fake cough test)
Again, as a result of the product’s post-surgery adjustability, no such unscientific test will be required to try to ascertain an optimal setting for each patient.

Decision on Setting Tension (too tight or too loose)
The post-surgery adjustability feature of the PMD-FCD is, of course, a significant technological advancement, as it will allow each surgeon to make the optimal adjustment for each patient without having to make such a critical judgment as to “too loose” or “too tight” at the time of surgery, or any other time. Accordingly, all of the surgeons that perform the implant of the PMD-FCD, will never have to err on the side of too loose, rather than too tight.

Slings Create Unnatural Tension (erosion and necrosis threats)
Although there always remains the threat of erosion, necrosis, or infection when introducing an implanted product in a surgical procedure, it is the Company’s contention that the number of cases that have these associated adverse events will be significantly less, and the level of severity of the adverse events will also be significantly less, than seen in sling or even bladder-neck suture suspension procedures (which would also include a comparison to the artificial sphincter device, as well) particularly as a result of the adjustability of the product and the fact that the product is implanted using a tension-free placement.

Tension-Free Tape Completely Surrounds Urethra
As discussed above, the PMD-FCD is a tension-free product just as is the new Tension-Free Tape (TFVT) and artificial sphincter device. However, what distinguishes the PMD-FCD greatly from the TFVT and artificial sphincter device is the PMD-FCD’s adjustability, and also that the PMD-FCD does not completely surround the urethra like both the TFVT and the artificial sphincter device, which allows the urethra better access to surrounding fluids and capillary blood flow than either of those two products. There is far less chance for strangulation of the vessel, and accordingly, far less chance for adverse events associated with such strangulations. The PMD-FCD has also been designed to allow for catheterization of any patient in the event of equipment failure, not usually possible if either the TFVT or artificial sphincter device has over-strangulated the urethra.

In short, the probable efficacy improvements and reduction in adverse events that are the promise of the PMD-FCD in comparison to all of the other currently-approved severe UI treatment products and procedures, as a result of the FCD’s adjustability, are considerable.