Research Project
9147589
? DESCRIPTION (provided by applicant): Stress urinary incontinence (SUI) in women is an increase of pelvic floor compliance which results in decrease of urethral pressure, typically through childbirth, and presents as urine leakage during exertion. SUI has significant impact on women's health, including an association with increased levels of depression. Curative options are limited to the invasive surgical insertion of a tape implant which limits the mobility of the urethra. Bulking agents injected in the peri-urethral tissue are a longstanding effective but temporary treatment. Pharmaceuticals are relatively new, prohibitively expensive, and there is no track record of long term efficacy. The remaining 14 million women are relegated to the palliative approaches of wearing absorptive pads or diapers. A substantial clinical need exists for a noninvasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations of minimally-invasive thermal techniques have demonstrated targeted thermal modification of tissue can reduce symptoms of SUI. These techniques have shown promise, but are more invasive than the current surgical options and are less effective. Therapeutic and interstitial ultrasound devices are an innovative technology under development by our group for delivering thermal therapy for treating cancer, as well as uterine fibroids, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, greater radial thermal penetration, and fast treatment times. We propose to develop this ultrasound technology specifically for the treatment of SUI; this technology has potential to provide a superior minimally-invasive heating technique for treating SUI with the promise of more accurate and thorough targeting, protection of critical non-targeted tissue (e.g., urethra, vaginal wall), more accessibility to a larger numbe of SUI patients, and faster procedure times. The objective of this Phase I research plan is to extend existing technology and develop transurethral therapeutic ultrasound applicators specific for selective and conformal thermal therapy of specific tissue structures required for successful treatment of SUI. Empirical design, bench experiments, biothermal and acoustic modeling, together with experimental testing in both ex-vivo tissues and a pilot in-vivo study in older ewes GU tract will be used for design feedback and to characterize device performance, as well as assess the technical and potential clinical feasibility. These results will be applied to the development and understanding of refined devices and potential treatment approaches in preparation for the ultimate goal of product development and clinical implementation during Phase II.
