The purpose of this Phase I Proposal is to demonstrate the utility of magnetic attraction technology for a simple, easy to use, urethral occlusive device for men with urinary incontinence following impaired sphincter function. Recent advances in magnetic materials have made it possible to fabricate lightweight, yet strong enough, magnets that can exert sufficient forces over the distances anticipated in typical urethral anatomies. The proposed configuration of this device consists of two components: 1) an implanted magnetic material positioned between the corpora cavernosa and urethra, and 2) an external magnet that is geometrically matched with the implanted component and attached to the surface of the penis in such a way as to be optimally aligned with it. The research will proceed in several phases: 1) a bench technique to allow characterization of the magnet strength and behavior in relation to a penile analog, 2) human cadaveric range finding experimentation to identify anatomical sizing, positioning and surgical constraints as well as magnetic strengths required for urethral occlusion, 3) a tooling phase to produce the external penile retention mechanism and prototype fabrication, 4) an iterative human cadaveric study to evaluate the tooled retention mechanism and implant component and 5) chronic animal implants to evaluate the effects of prolonged tissue compression, urine leakage pressure thresholds, encapsulation and reaction to the implanted component. Successful demonstration of a safe and effective occlusive force levels will encourage a Phase II continuation study with devices prepared for humans. Successful human use of this technology will provide a significant competitive advantage over existing implantable devices and external penile compressive devices for male urinary incontinence, a market that currently exceeds $50 million annual sales, and could significantly reduce the multi-billion dollar cost of managing patients with absorbency products.
