September 14, 2016Â (Ft. Lauderdale, Florida)
Severe UI (and/or FI and even urinary retention) in males results from a number ofÂ causes, including as a result of other primary diseases and conditions (including;Â Parkinsonâ€™s, Multiple Sclerosis, Muscular Dystrophy, dementia and Alzheimerâ€™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 moreÂ 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 technologyÂ invented and developed by PMD is expected to optimally treat most such cases with theÂ simple (15-20 minute) implant of our Bluetooth remote-controlled and adjustableÂ urethral valve Flow Control device with the follow-on version of the technology expectedÂ to do the same for the FI cases, as well.
Incontinent Insight – Prostate Health and Urinary IncontinenceÂ It seems almost inevitable that at least half the male population, if they live long enough,Â will experience some level of health problems with their prostate.Â At least one-in- four men will be diagnosed with prostate cancer, some cases of whichÂ will become near-term life-threatening, while many other cases will be of the â€œslowÂ growingâ€ variety, which will take many years, perhaps even decades, to develop into theÂ life-threatening form of the disease.
For those men who are forced to treat their fast-growing prostate cancer, or choose toÂ treat their slow-growing prostate cancer, aggressively, with any one of the multipleÂ different new treatment options currently available, many times the treatment can resultÂ in either or both urinary incontinence (UI) and/or erectile dysfunction (ED), as a result ofÂ the procedures themselves, which inadvertently, in a fairly substantial number of theÂ 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 conditionÂ known as benign prostate hyperplasia (BPH), which results in the growth of the prostateÂ gland.
Patients who have BPH, often times, also develop UI, making prostate problems one ofÂ the most prevalent causes of UI in men.Â Accordingly, PMDâ€™s bionic remote-telemetry- controlled urethral valve implant is likely toÂ become the new â€œgold standardâ€ treatment for men who have severe UI caused byÂ either BPH or as a result of the aggressive treatment of their prostate cancer.Â For these men, imagine never having to pack another diaper in your briefcase whenÂ going out on a business meeting or getaway.Â The PMD Flow Control Device (FCD) will truly represent a return to freedom and an endÂ to the social embarrassment experienced after prostate treatment.Â 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 KidneyÂ 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 accidentalÂ leakage of urine during activities such as coughing, laughing, sneezing, or lifting heavyÂ objects. These surgical procedures are called mid-urethral slings. The procedures insert aÂ mesh sling or "hammock" to support the bladder neck so that urine does not leak. BothÂ procedures have been approved by the FDA and have been shown to be safe and successfulÂ in treating stress urinary incontinence. However, we do not know if one is better than theÂ 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 andÂ the sling procedure. Both of these surgeries have been performed for decades and haveÂ estimated cure rates of 60% to 90%. However, the long-term outcomes have not beenÂ studied. It is unclear whether one of these surgeries is better than the other and should beÂ offered to all women. The UITN plans to answer this important question.
Notwithstanding this study conducted by the Urinary Incontinence Treatment NetworkÂ (UITN), there have been an exhausted number of studies done on the same twoÂ procedures. Unfortunately, most of the studies done either had too few participants orÂ did not carry-out the follow-up evaluations for a sufficient length of time (five years) toÂ shed real light on the â€œreal worldâ€ findings and results.
Accordingly, it should be noted that there are more than a dozen different sling materialÂ choices and over 200 different protocols for implanting these slings and/or bladder-neckÂ suspension surgical procedures (including the â€œBurchâ€), which begs the question; If any of these sling materials or suspension surgical procedures were universally accepted asÂ 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 efficacyÂ of, and adverse events associated with, these sling and bladder-neck suspensionÂ 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 farÂ worse than originally postulated and reported, while the efficacy rates have beenÂ substantially over-exaggerated.Â In fact, one significant study (â€œThe Incidence and Prevalence of Stress UrinaryÂ Incontinence, Medscape Â© 1994-2003â€, by Ananias C. Diokno, MD) concluded that afterÂ 5 years, only 45% of the respondents who had a surgical procedure to correct their UI,Â would recommend such a procedure to others.Â In sharp contrast to the current array of sling surgical implants (currently considered theÂ state-of- the-art), which have no adjustability feature, the Precision Medical DevicesÂ (PMD) Flow Control Device (FCD), a remote-telemetry- controlled bionic urethra valveÂ implant, is expected to become the new â€œgold standardâ€ treatment of severe UI mostlyÂ 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 ofÂ use, having a more modest adverse events profile and lower risk profile as compared toÂ all of the other currently-approved severe UI products and procedures (especially theÂ more invasive products and/or procedures) will just add to the benefits derived fromÂ using it. The product is expected to last a lifetime, with little or no deterioration in itsÂ efficacy.