Jeremy Myers, MD, associate professor in Surgery at University of Utah Health developed a clinical trial to evaluate a new method to improve bladder function in patients with severe spinal injuries. But he was worried. Would he be able to recruit enough patients for this study?
According to Myers, there is a narrow window — just three months after an injury — for these patients to begin treatment. Without treatment, the bladder loses flexibility and can no longer contract and empty. Spinal injury patients must contend with increased urinary tract infections, limited bladder capacity, and urinary incontinence.
During the initial critical months, most patients are still recovering from the shock of their new normal, hoping that their condition will improve. They are not ready to think about future quality of life issues, like deteriorating bladder function.
“Many patients are open to this conversation once they transition home, but by this time some changes are irreversible,” he said.
To ensure the study moves forward, Myers decided to seek help from the Center for Clinical and Translational Science (CCTS) Hub Liaison Team, which functions as the front door to the Trial Innovation Network, a National Institutes of Health (NIH) initiative.
Myers received help organizing a centralized Internal Review to streamline contracting with his clinical trial colleagues at the University of Michigan and University of Minnesota. He also received an initial consultation with the Recruitment Innovation Center colleagues at Vanderbilt University to improve recruitment from this challenging patient population.
With funding from the Department of Defense, Meyers hopes to recruit 60 patients for the study, with 10 patients at each site (Utah, Michigan, and Minnesota) for every year of the study. In the clinical trial, Myers will implant a device, similar to a pace maker, along the patient’s tail bone. The device will emit continued stimulation that will prevent the bladder from stiffening.
After implanting the device, the study team will meet with the patients several times to evaluate bladder function and review the patient’s bladder journal and perceived quality of life.
“We do not fully understand why, but we believe that continued stimulation will preserve favorable bladder function,” he said. Myers developed this clinical trial to expand on an earlier, non-randomized study that showed that stimulation shortly after spinal cord injury improved bladder capacity.
There’s a lot of work to be done but Myers is optimistic that with the support from CCTS, he will bring the technology to the people who need it most.
The National Center for Advancing Translational Science (NCATS) Trial Innovation Network consist of the three Trial Innovation Centers and the Recruitment Innovation Center located at the University of Utah, Duke University, Vanderbilt University, Johns Hopkins Hospital, and Tufts University, as well as more than 60 Clinical and Translational Science Award (CTSA) Hubs.
Trial Innovation Network aims to develop operational hypothesis around clinical research to implement innovative, collaborative solutions to transform clinical and translation research.
To participate in the Trial Innovation Network, investigators must first contact the CCTS Hub Liaison Team to submit a proposal to the Network. Proposals undergo a review by subject matter experts to strengthen the study, identify local expertise to support the application, and receive CTSA endorsement of the application. This process can happen at any stage of planning for a multi-center clinical research trial. Trial Innovation Network Initial Consultations are typically completed within 30–60 days of proposal submission.