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Image-Guided Transurethral HIFU for Genitourinary Therapy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DK108458-01
Agency Tracking Number: R44DK108458
Amount: $1,497,405.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PAR14-088
Solicitation Year: 2014
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-09-25
Award End Date (Contract End Date): 2018-08-31
Small Business Information
Savoy, IL 61874-9510
United States
DUNS: 606222896
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (217) 778-0900
Business Contact
Phone: (217) 239-0901
Research Institution

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 womenandapos 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 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 PUBLIC HEALTH RELEVANCE Stress urinary incontinence SUI is a condition which affects more than million American women Those who seek treatment results in close to surgical and other therapeutic interventions each year The condition presents as inadvertent urinary leakage during exertion such as exercise lifting or laughing The curative interventions
currently available are either invasive surgery implants or too expensive The vast majority seek palliative therapies such as absorptive pads and diapers as their only alternative The problems associated with SUI extend beyond the apparent symptoms of inadvertent urinary leakage The associated effects on freedom of activity embarrassment self esteem and mental health SUI has a direct association with depression in sufferers are significant There is
a strong need for a noninvasive and relatively inexpensive method to address the condition in these womenandapos s lives This proposed new high intensity ultrasound treatment would address both of those issues Therapeutic ultrasound requires no incisions and may be performed with topical anesthetic The proposed design of the delivery device will be inexpensive outpatient office based quick and simple minute single treatment procedure allowing many women to receive a curative treatment for a lower payment than they spend annually on palliative absorptive pads and diapers Moreover the proposed technique aims to treat SUI using the concept of personalized medicine where treatment energy pattern is administered according to the respective anatomy of the patient As such this treatment will provide a potential cure for the nearly million women who remain untreated

* Information listed above is at the time of submission. *

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