September 14, 2016 (Ft. Lauderdale, Florida)

Severe UI (and/or FI and even urinary retention) in males results from a number of causes, including as a result of other primary diseases and conditions (including; Parkinson’s, Multiple Sclerosis, Muscular Dystrophy, dementia and Alzheimer’s and just age related degeneration exacerbated by smoking, obesity and/or lung disease) but overwhelmingly happens as result of adverse events experienced during the more invasive procedures used to treat prostate disease affecting over 2 million males in the U.S. and over 5 million males in the industrialized nations of the world. The technology invented and developed by PMD is expected to optimally treat most such cases with the simple (15-20 minute) implant of our Bluetooth remote-controlled and adjustable urethral valve Flow Control device with the follow-on version of the technology expected to do the same for the FI cases, as well.

Incontinent Insight – Prostate Health and Urinary Incontinence It seems almost inevitable that at least half the male population, if they live long enough, will experience some level of health problems with their prostate. At least one-in- four men will be diagnosed with prostate cancer, some cases of which will become near-term life-threatening, while many other cases will be of the “slow growing” variety, which will take many years, perhaps even decades, to develop into the life-threatening form of the disease.

For those men who are forced to treat their fast-growing prostate cancer, or choose to treat their slow-growing prostate cancer, aggressively, with any one of the multiple different new treatment options currently available, many times the treatment can result in either or both urinary incontinence (UI) and/or erectile dysfunction (ED), as a result of the procedures themselves, which inadvertently, in a fairly substantial number of the cases, cause permanent nerve damage to the tissue around the urethra.

But prostate problems do not just manifest as cancer, but also as a benign condition known as benign prostate hyperplasia (BPH), which results in the growth of the prostate gland.

Patients who have BPH, often times, also develop UI, making prostate problems one of the most prevalent causes of UI in men. Accordingly, PMD’s bionic remote-telemetry- controlled urethral valve implant is likely to become the new “gold standard” treatment for men who have severe UI caused by either BPH or as a result of the aggressive treatment of their prostate cancer. For these men, imagine never having to pack another diaper in your briefcase when going out on a business meeting or getaway. The PMD Flow Control Device (FCD) will truly represent a return to freedom and an end to the social embarrassment experienced after prostate treatment. The Urinary Incontinence Treatment Network (UITN) is a group of urologists and urogynecologists from all over the country who are conducting research on the treatment of urinary incontinence, or accidental loss of urine. This research is being funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Child Health and Human Development (NICHD).


TOMUS (Trial Of Mid-Urethral Slings)

The TOMUS study will compare the outcomes of minimally invasive surgical procedures to treat stress urinary incontinence in women. Stress urinary incontinence is the accidental leakage of urine during activities such as coughing, laughing, sneezing, or lifting heavy objects. These surgical procedures are called mid-urethral slings. The procedures insert a mesh sling or "hammock" to support the bladder neck so that urine does not leak. Both procedures have been approved by the FDA and have been shown to be safe and successful in treating stress urinary incontinence. However, we do not know if one is better than the other. This study will answer that question.


SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial)

This study is comparing the long-term outcomes of two commonly performed surgeries for the treatment of stress urinary incontinence. The two surgeries are the Burch procedure and the sling procedure. Both of these surgeries have been performed for decades and have estimated cure rates of 60% to 90%. However, the long-term outcomes have not been studied. It is unclear whether one of these surgeries is better than the other and should be offered to all women. The UITN plans to answer this important question.

Incontinent Insight

Notwithstanding this study conducted by the Urinary Incontinence Treatment Network (UITN), there have been an exhausted number of studies done on the same two procedures. Unfortunately, most of the studies done either had too few participants or did not carry-out the follow-up evaluations for a sufficient length of time (five years) to shed real light on the “real world” findings and results.

Accordingly, it should be noted that there are more than a dozen different sling material choices and over 200 different protocols for implanting these slings and/or bladder-neck suspension surgical procedures (including the “Burch”), which begs the question; If any of these sling materials or suspension surgical procedures were universally accepted as being the most efficacious, why does there continue to be so many different choices?

Additionally, there have been few studies that have tabulated the longer term efficacy of, and adverse events associated with, these sling and bladder-neck suspension surgical procedures, but in the few instances that such studies have been done, the failure and adverse event rates, and the severity of the adverse events, have been far worse than originally postulated and reported, while the efficacy rates have been substantially over-exaggerated. In fact, one significant study (“The Incidence and Prevalence of Stress Urinary Incontinence, Medscape © 1994-2003”, by Ananias C. Diokno, MD) concluded that after 5 years, only 45% of the respondents who had a surgical procedure to correct their UI, would recommend such a procedure to others. In sharp contrast to the current array of sling surgical implants (currently considered the state-of- the-art), which have no adjustability feature, the Precision Medical Devices (PMD) Flow Control Device (FCD), a remote-telemetry- controlled bionic urethra valve implant, is expected to become the new “gold standard” treatment of severe UI mostly as a result of its remote adjustability feature.

The fact that the FCD product will set new standards in the ease of implant, the ease of use, having a more modest adverse events profile and lower risk profile as compared to all of the other currently-approved severe UI products and procedures (especially the more invasive products and/or procedures) will just add to the benefits derived from using it. The product is expected to last a lifetime, with little or no deterioration in its efficacy.