The long term goal of this project is to develop a non-invasive urodynamic device for use in the diagnosis and treatment of lower urogenital tract disorders. This method will be applicable to differential diagnosis of bladder and urethral disorders such as benign prostatic hypertrophy (BPH) in males and detrusor (bladder) weakness in both sexes. Such disorders affect a very large fraction of the older population throughout the world. Presently available urodynamic diagnostic procedures are invasive, and are associated with a significant rate of infection and other complications. Also, the invasive procedures are complicated, expensive, and uncomfortable, and therefore cannot be conveniently repeated to confirm pathological findings or to evaluate response to treatment. The BioFlo methodology will be completely non- invasive, simple and inexpensive, yet can be automated enough to be carried out as an office procedure without need for highly trained personnel. In Phase I we aim to validate the design principles and to determine the technical specifications needed to meet clinical requirements for application to males. We will then test the resulting device, both in the design laboratory as well as on groups of normal and urologically dysfunctional males. These results will form the basis for more detailed technical development and clinical trials in Phase II, which-will also extend the methodology to females.
About 15% of the U.S. population are over 65, and this number is growing rapidly. Due to lack of simple, inexpensive, non-invasive diagnostic methods for urological conditions, incorrect diagnosis and unsuccessful treatment for just one such condition (BPH) costs the U.S. economy about a billion dollars annually. Thus the diagnostic market for male urogenital tract problems has great potential for BioFlo.
