Disposable Valved Intraurethral Catheter Feasibility
Small Business Information
UROVALVE, INC., 211 WARREN ST, NEWARK, NJ, 07103
AbstractDESCRIPTION (provided by applicant): The objectives of this proposed Phase II SBIR project are to refine the SurinateTM disposable valved intraurethral catheter to make it easier for the patient to operate, more reliable and easier to insert and extract th an the prototype that was tested in the Phase I SBIR feasibility study. The effectiveness and safety of the refined design will be demonstrated in a pilot clinical study. Surinate(tm) is intended to treat chronic male urinary retention (such as that caused by spinal cord injury and neurological diseases) and acute male urinary retention (such as that caused by prostrate hypertrophy). The valved catheter is controllable by the patient and will be an innovative treatment alternative for users of Foley and int ermittent catheters, allowing patients the freedom to urinate at their convenience, thereby improving the quality of life for an estimated 375,000 men who must deal with chronic urinary retention due to spinal cord injury (SCI), late-stage multiple scleros is, and other neurological conditions. Despite improvements in medical care, these patients continue to experience significant morbidity related to their urinary tracts. Much of this morbidity is due to the limitations of indwelling, intermittent and exter nal catheter technology, which has not significantly improved in decades. Surinate(tm) offers many of the benefits of intermittent catheterization, but should be much easier to use and cause significantly fewer urinary tract problems. The Surinate(tm) valv ed catheter is designed to be easily inserted into the urethra without surgery, extracted easily, and replaced every 28 days. The Phase I feasibility study demonstrated that the valve was mechanically reliable, and that the valved catheter could be inserte d successfully without surgery and remained stable in the urethra. Although there were a tolerable number of adverse events, none was serious or unanticipated. Improvements are intended to make the insertion procedure simpler; the valved catheter easier fo r the patient to operate; increase flow rate; and simplify removal using the extraction tool. The objectives of the Phase II effort are to: (1) develop and manufacture prototype units; (2) conduct design verification testing to demonstrate that desired per formance characteristics have been achieved with the prototypes; (3) transfer manufacturing of the Surinate(tm) devices to an FDA- approved contract manufacturer that meets ISO 13485 standards, (4) perform laboratory verification testing of the manufacture d devices at Urovalve, Inc., (5) Finalize Case Report Forms and Informed Consent ; obtain approval from FDA for an Investigational Device Exemption and Institutional Review Board approval to conduct the human clinical under the protocol that has been writt en in collaboration with the Boston VA Healthcare System and (6) conduct the Phase II pilot clinical to demonstrate safe and effective operation of all components in both clinical and home-use settings. Up to 40 male veterans with SCI will be screened to h ave 20 patients complete a crossover study to compare the effectiveness and safety of the Surinate(tm) disposable intraurethral valved-catheter to intermittent catheterization during a 30 day period (14 days using each device). RESEACH and RELATED: Other P roject Information Item 7: Project Narrative The Surinate(tm) catheter system will bring dramatic improvement to the health and qualify of life for many individuals who suffer urinary retention, including those due to spinal cord injury. No devices current ly available or known to be in development for patients who suffer urinary retention combine the utility, ease of use, and health benefits and cost effectiveness of SurinateTM. The SurinateTM catheterization system offers solutions to the problems of quali ty of life, urinary tract infections, and substantial reliance on healthcare workers associated with the existing catheters. Neither urologists nor patients c
* information listed above is at the time of submission.