Connected Catheter Clinical Validation Study (CVS)
Abstract
People with neurogenic bladder have lost bladder control because of a neurological disease or injury. People with Spinal Cord Injury (SCI), multiple sclerosis (MS), stroke, traumatic brain injury (TBI), Parkinson’s Disease and even diabetes can have neurogenic bladder. Individuals with neurogenic bladder suffer bladder overflow incontinence, bladder spasms and have to use catheters as a means to empty their bladder. Using catheters is inconvenient, expensive, and associated with an increased risk of genito-urinary trauma and infection in the form of Catheter Associated Urinary Tract Infection (CAUTIs). To ease the suffering of individuals with neurogenic bladder and to give them control over their bladder voiding, Spinal Singularity is developing the Connected Catheter 2P System (C2P). The C2P is a catheter system designed for male chronic catheter users with neurogenic bladder. The C2P resides completely inside the person and is controlled by a handheld controller, giving the user control of the voiding process. Since the C2P system does not require frequent self-catheterization, we believe users will prefer using the C2P over Foleys or CIC methods. In addition, since the frequent insertions and removals of the CIC method and the external to internal line found with Foley catheters is gone, we believe the chance of bacterial introduction, and hopefully, the risk of contracting a CAUTI will be decreased in C2P users. The objective of this study is to compare the C2P system to Foley Catheterization and CIC methods in a wellcontrolled crossover clinical study. Primary outcome measures will include successful device insertion and removal, successful bladder voiding, and no leaking after bladder voiding. As secondary outcome measures for each catheterization method we will compare adverse events such as symptomatic UTI and stricture formation, perform a urine analysis for markers of infection (e.g., bacterial colonies and leukocyte counts), examine the volume of urine voided, the urine flow rate, and assess Quality of Life and User Experience. Finally, we will examine UTI Symptom Scores with the USQNB questionnaire. The C2P will specifically help male, neurogenic bladder patients by giving them control over when and how often they void their bladder. The C2P has the potential to revolutionize male catheterization by potentially reducing CAUTIs and because it is a minimally invasive catheter option for neurogenic bladder patients compared to selfcatheterization. A future user interested in the C2P could be using the device for bladder control after one short doctor’s office visit where they learn how to insert, remove and operate the C2P. The C2P has the potential to greatly enhance the quality of life of SCI patients. Regaining bowel and bladder function was ranked second in a survey of nearly 700 individuals living with SCI13. Indeed, one early user of the C2P system said, “this is the first time I have really urinated in three years” and that “I will be able to start drinking more water, which I stopped doing because I hate using catheters so much.” This statement begins to reflect how impactful we at Spinal Singularity feel the C2P system will be not only for SCI patients but for all neurogenic bladder users. With this clinical study, Spinal Singularity hopes to gather more data on C2P use to directly compare it to the two most common catheterization methods (Foley catheterization and CIC), obtain the necessary data for FDA 510(k) marketing clearance to allow widespread distribution and use of the C2P system, and to demonstrate the superiority of the C2P system, not only for improving quality of life, but catheter function as well.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910370
Entities
People
- Bill Colone
Organizations
- United States Army