The focus of the present application is to develop a new in vivo sensor and associated instrumentation to enable the intraluminal monitoring of tissue characteristics. The design specifications incorporate a directionally sensitive sensor probe capable of evaluating tissue compliance, displacement contact pressure and force of contraction. This instrument will be used to assess the static and dynamic biomechanical characteristic of the vagina and its response to active voluntary pelvic floor contractions and passive compression produced by Valsalva. Movement of the vagina can be displayed instantly on the monitor to provide feedback to the patient. This sensor system can be useful in resolving the cause of female urinary incontinence, which affects up to 35% of adult population by enhancing the value of the physical examination and supplementing urodynamic tests. While useful in the evaluation of bladder/urethral function, urodynamics does not provide relevant information on the influence of the pelvic floor, in maintaining continence. Indeed appropriate evaluation of pelvic floor function is critical in determining whether conservative management, such as strengthening with Kegel exercises, can be useful for treatment. We propose to introduce forthwith a novel in vivo sensor that will enable the quantitative testing of pelvic floor function in a manner corresponding to urodynamics. The design specifications of this instrument are based upon knowledge acquired from imaging, physical examination and urodynamics. We anticipate that this probe will be fabricated so that it can be handled readily by medical personnel with the minimum of training. We expect that this probe will by used by urologists, gynecologists and physical therapists in association with urodynamic testing or independently. We intend to build a prototype probe, write associated software for data collection, evaluation and calibration of transducers and identify frequency response parameters followed by a few pilot studies to obtain data from human subjects with varying etiology of urinary continence.
