GT UROLOGICAL, LLC — Department of Health and Human Services SBIR Phase I: Hydraulic Artificial Urinary Sphincter - HydrAUS GT Urological, LLC. has prepared this

Description

Hydraulic Artificial Urinary Sphincter - HydrAUS GT Urological, LLC. has prepared this NIH SBIR Phase I Grant Application entitled Hydraulic Artificial Urinary Sphincter - HydrAUS to detail goals and activities related to the design and development ofan implantable, hydraulic urinary sphincter intended to safely and effectively prevent urinary leakage in males and females suffering from Urinary Incontinence (UI). UI frequently occurs in males who have undergone surgery to remove their cancerous prostates. Females frequently become incontinent due to child birth injury. HydrAUS offers significant advantages over existing urinary incontinence treatments that impart a permanent partial obstruction to voiding or require extensive surgery such as bulking agents, urethral slings and inflatable cuffs. The only commercially available inflatable cuff, the AMS AUS 800(R) is unable to accommodate changes in intra-abdominal pressure induced by leak producing stressful events and cannot have its occlusivepressure adjusted post-operatively. HydrAUS advantages include: 1) simplified implant surgery that will require less surgical time, fewer incisions, and reduced post operative trauma; 2) improved mechanical reliability; and 3) post-operative pressureadjustment. Preliminary activities include design and development engineering, prototype development, bench testing, human cadaveric studies, short term animal implant testing. It is GT Urological's intent to perform additional HydrAUS development beyond the scope of this grant which will lead to HydrAUS commercialization.