SBIR-STTR Award

Urovalve, Inc. has developed a user operated valved catheter to enable people with chronic urinary retention to pursue more active lives and decrease the high incidence of urinary tract infections. The device is a short silicone catheter with a malecot to retain it in the bladder and a miniature proximity valve to control flow. The tiny fluid flow valve is opened by a switching magnet that is held near the body and closes when the magnet is moved away. The device is inserted into the urethra without surgery, is extracted easily, and will be intended to be replaced every 28 days. This research will perform feasibility tests on the intraurethral valved catheter to: refine clinical techniques for insertion and extraction; demonstrate stability of catheter positioning in urethra; demonstrate that the device works effectively and is safe during a short-term trial. Five spinal cord injured subjects having urinary retention but otherwise normal urethras will receive implants and be monitored for four days within a rehabilitation hospital. The stents will bridge the urethral sphincters from bladder neck to bulbous urethra. Subjects will perform normal daily living activities to test stability of stent placement and will be monitored for clinical signs, residual volumes and understanding of valve operation. Subjects will open the valves intermittently using hand held actuator magnets. Implantation methods, using a protective sheath, and removal methods, using an extraction tool, will be tested for safety. Implanted stents will be monitored for: migration from implant position; urine leakage; clogging; and closure due to stent deformation. Stent extraction forces will be measured and recovered stents will be examined for accumulation of renal debris and physical integrity and be cultured for bacteria accumulation. Devices currently available are either very simple catheters (Foley or Intermittent Catheter) or very high tech electro-mechanical devices that require extensive surgical implantation. No inventions currently available or in development combine the utility and health-care cost benefits of Urovalve's invention.

Thesaurus Terms:
biomedical equipment development, consumable /disposable biomedical equipment, silicone rubber, urethra, urinary catheterization functional ability, implant, physical therapy, urinary tract disorder clinical research, human subject, male, patient oriented research, urinalysis

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 than 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 intermittent 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 sclerosis, 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 external 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) valved 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 inserted 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 for 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 performance 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 manufactured 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 written 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 have 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 & RELATED: Other Project 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 currently 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 quality of life, urinary tract infections, and substantial reliance on healthcare workers associated with the existing catheters. Neither urologists nor patients consider currently available devices to be satisfactory to the patients' comfort, cost of care, or medical performance.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
Catheterization, Male, Performance Caregiver, Conditioning, Cost Effectiveness, Environment, Experience, Health, Health Care, Human, Hypertrophy, Kidney, Lead, Literature Survey, Multiple Sclerosis, Nervous System Disorder, Patient Care, Physician, Prostate, Quality Of Life, Sectioning, Solution, Spinal Cord Injury, Surgery, Trauma, Urethra, Urinary Calculi, Urinary Tract, Urinary Tract Infection, Veteran Clinical Research