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Bladder dysfunction due to aging, injury, or disease, affects over 3 million people in the U.S. and over 21 million globally as well as countless elderly in chronic care. Management involves recurrent and chronic catheterization or surgical urinary diversion. These lead inevitably to chronic and recurrent urinary tract infections (RUTIs). RUTIs significantly increase morbidity and mortality as well as the economic burden of these conditions. They also constitute the largest institutional reservoir of multi-drug resistant ( MDR) Gram negative rod( GNR) bacteria that now threaten to render antibiotics impotent.
Our Team at MGH ( comprised of experts in Infectious Diseases, Urology, Laser Medicine, and Drug/Device Development) proposes an innovative drug-device combination that can break the cycle of RUTI->antibiotic Rx->increased MDR GNR resistance. We have developed a proprietary photodynamic therapeutic (PDT) combination of existing FDA-approved generic compounds with good safety profiles that are already in clinical use in the bladder. Properly combined and activated by low-power red light, the two compounds create a proprietary PDT agent, preferentially concentrated in all bacteria and candida, that can decrease colony-counts by 6-7 logs in minutes after low-power light exposure, without the possibility of bacterial resistance developing. To deliver this anti-microbial PDT, we have invented at MGH a modified, standard clinical 3-channel Foley catheter, which we termed the "Photonic Foley". The photosensitizing solution can be delivered to the bladder through the 3-channel Photonic Foley catheter. One channel provides urinary drainage but also provides a means of delivery and drainage of the photosensitzer. Another channel incorporates a fiber optic cable, while a third provides a diffuser to deliver low-power, LED red light (~ 660 nm) for photoactivation of the infused drug. Light delivered after introduction of the photosensitizer causes electron transfer from the excited state of the photosensitizer, producing free radicals that kill bacteria without damaging the bladder lining. Since PDT killing of bacteria uses a fundamental mechanism of photochemical damage to cell wall constituent molecules, it is unlikely that bacteria will develop resistance to this bactericidal mechanism, making its chronic use possible and reducing the likelihood of drug-resistance.
We have developed a rat model of PDT/ laser treatment of UTI's in rats that demonstrates the proof- of-principle. We initially intend to develop this for office and hospital-based Urologic treatments, but hope to extend the technology to enable its' use in chronic care facilities, and even the home, using smaller, more portable devices.