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Solutions for Self-Control of Urinary Function and Control

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: To develop, design, and demonstrate new technology or therapies for injured Service Members that will allow patient or caregiver control over urination. 

DESCRIPTION: The Department of Defense has an urgent need for clinical genitourinary technologies that will allow for patients to control their own urine flow. While proposed solutions may be suitable for those who have lost tissue as the result of injury, the primary user will likely be those suffering from neurogenic dysfunction. Urinary dysfunction may be the result of traumatic injury to the lower body or may be neurogenic in nature, resulting from damage or disease of the central nervous system [1]. Traumatic injuries may involve damage or complete loss of tissues necessary for urinary function. Neurogenic damage may not affect specific genitourinary tissues, but can still prevent control over urinary function. Approximately 70-84% of spinal cord injury (SCI) patients will have neurogenic bladder dysfunction (NBD), translating to ~32,000 SCI veterans with NBD [2]. The current clinical standard for treatment of bladder and urinary tract defects is catheterization, which can range from intermittent catheterization, requiring no surgery or permanent implants, to creation of a stoma, bypassing the urethra to empty the bladder directly. Intermittent catheterization is the use, several times a day, of a straight catheter that can be done independently by some patients, or a Foley catheter that allows continuous drainage into a drainage bag worn by the patient. The alternative is creation of a stoma that allows insertion of a catheter. The drawbacks for these procedures are the need for repeated catheter insertion and the need for external collection bags. For Service Members sustaining these injuries, the use of a catheter may be required for decades. There is an inherent risk of infection and catheters may become blocked. Some evidence indicates certain bacteria encourage the development of encrustations that may block the catheter within 24 hours [3]. Catheter related urinary tract infections contribute to more than 40% of nosocomial hospital infections [4]. In addition to these risks, the ongoing costs for lifelong catheterization can be high. The average life span post SCI is over 40 years [5]. With catheters, pads and other supplies costing ~$600/month, this translates to almost $350,000 in a lifetime. For the VA alone, this adds up to over $23 million per year. The ultimate goal of this project is to develop new technologies or therapies that can replace standard catheterization to allow a user to control their own urinary function. The ability to restore urinary function to injured Service Members would improve quality of life, enhance the ability to engage in the activities of daily living, and reduce the need for hospital visits for catheter care. This would be used at Role of Care 4 and with VA populations.  

PHASE I: In the Phase I effort, innovative efforts for restoring urinary function will be conceptualized and designed. Such solutions should be devices, and should not include cellular, tissue or biological components. Phase I efforts can support early concept work (i.e., in vitro studies), or efforts necessary to support a regulatory submission, which do not include animal or human studies, such as stability studies, shipping studies, etc. Proposed technologies should be formulated, and the fabrication or production procedures should be developed for a representative device. The Phase I effort should also include fabrication experiments and benchmarking that demonstrate an adequate capability for meeting the expected challenges in fabricating the proposed technology. It is expected that physical attributes of devices such as patency, user control, urine retention and incontinence, and infection control will be predicted as a function of the material and device structure. Specific milestones for devices include the ability for the user to control urination, to control potential bacterial colonization or infection, and to maintain patency. Proposed solutions should: 1) be gender neutral, 2) be suitable for both urinary tract trauma and neurogenic bladder dysfunction; 3) be both anatomical and functional; 4) replace chronic catheter usage; and 5) be operable by either a patient or a caregiver without specialized training. Proposed solutions should not: 1) rely on nerve stimulation or nerve conductivity to enable function; 2) require diversion of urine to external containers; 3) require specialized clothing that would prevent normal socialization; 4) require frequent readjustments or maintenance by health care personnel; 5) contain components that open within the urine stream; 6) require metals to be in contact with urine; 7) increase the risk of kidney stones; or 8) be solely focused on urine volume sensing. 

PHASE II: In the Phase II effort, a prototype technology or therapy should be fabricated and demonstrated. The performance of the technology should be fully evaluated in terms of patency, user control, urine retention and incontinence, and ability to resist bacterial colonization or infection. The last requirement is especially critical for implanted devices as unresolved bacterial contamination could be life threatening and require removal of an implant. Phase II results should demonstrate understanding of requirements to successfully enter Phase III, including how Phase II testing and validation will support a regulatory submission. Phase II studies may include animal or human studies, portions of effort associated with the same, or work necessary to support a regulatory submission which does not involve animal or human use, to include, but not limited to: manufacturing development, qualification, packaging, stability, or sterility studies, etc. The researcher shall also describe in detail the transition plan for the Phase III effort. The Food and Drug Administration regulatory requirements vary depending on the device classification. As part of the phase II effort, the performer is expected to develop a regulatory strategy to achieve FDA clearance for the new technology. Interactions with the FDA regarding the device classification and an Investigational Device Exemption (IDE), as appropriate, should be initiated. Essential design and development documentation to support FDA clearance, as described in the Quality System Regulation (21 CFR 820.30), should be captured including but not limited to design planning, input, output, review, verification, validation, transfer, changes, and a design history file. The project needs to deliver theoretical/experimental results that provide evidence of efficacy in animal models. The studies should be designed to support an application for FDA clearance. 

PHASE III: During phase III, it is envisioned that requirements to support an application for device clearance from the FDA should be completed. As part of that, scalability, repeatability and reliability of the proposed technology should be demonstrated. Devices should be fabricated using standard fabrication technologies and reliability. The proposal should include a commercialization or technology transition plan for the product that demonstrates how these requirements will be addressed. They include: 1) identifying a relevant patient population for clinical testing to evaluate safety and efficacy and 2) GMP manufacturing sufficient materials for evaluation. The small business should also provide a strategy to secure additional funding from non-SBIR government sources and /or the private sector to support these efforts. Potential DoD funding mechanisms include research programs managed by the Congressionally Directed Medical Research program (CDMRP), which can be found at www.cdmrp.army.mil. Relevant research programs may include the Spinal Cord Injury Research Program (SCIRP) or the Joint Warfighter Medical Research Program (JWMRP). This technology/therapy is envisioned for use in surgical intervention to repair urinary dysfunction in fixed medical treatment facilities. As such, the technology should have both military and civilian applications. Procurement of such technology would be at the discretion of the medical treatment facility. 

REFERENCES: 

1: Panicker JN, et al. Lower urinary tract dysfunction in the neurological patient: clinical assessment and management. Lancet Neurol. 2015 Jul

2: 14(7):720-32.

3:  Dorsher PT, McIntosh PM. Neurogenic Bladder. Adv Urol. 2012

4: 2012:816274. doi: 10.1155/2012/816274.

5:  Lowthian P. The dangers of long-term catheter drainage. Br J Nurs. 1998 Apr 9-22

6: 7(7):366-8, 370, 372 passim.

7:  Bronsema, D. A., Adams, J. R., Pallares, R., & Wenzel, R. P. (1993). Secular trends in rates and etiology of nosocomial urinary tract infections at a university hospital. Journal of Urology, 150, 414-416.

8:  Middleton JW, Dayton A, Walsh J, Rutkowski SB, Leong G, Duong S. Life expectancy after spinal cord injury: a 50-year study. Spinal Cord. 2012 Nov

9: 50(11):803-11. doi: 10.1038/sc.2012.55.

KEYWORDS: Catheter, Urinary Dysfunction, Neurogenic Dysfunction, Genitourinary, Intermittent Catheterization 

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