Needs, Priorities, and Attitudes of Individuals With Spinal Cord Injury Toward Nerve Stimulation Devices for Bladder and Bowel Function: A Survey - Beyond the Abstract

Neuromodulation devices are developed with a focus on safety, efficacy, and health economics. It is easy to neglect and often difficult to incorporate the opinions and views of the patient or potential recipient of the device into the design of medical technology. A recently published study in the Journal Spinal Cord reported the findings from a study focusing on the perspectives of people living with neurogenic bladder and/or bowel resulting from spinal cord injury (SCI). What makes this study unusual is the involvement from the very start of people living with the condition.

Biomedical engineers create technology to solve medical problems in people that they may never meet. Currently, neuromodulation therapies, such as sacral nerve or tibial nerve stimulation devices, are being created to help individuals that struggle with bladder and bowel incontinence. These novel devices affect bladder and bowel systems to relieve symptoms if the right nerves get the right electrical signal at the right time. As a demonstration of devices with this functionality expands, design and development must be guided by a clear understanding of the problem and what a successful solution looks like, not only to the clinician but also to the intended user.  

To gain this understanding, clinicians, scientists, and engineers partnered with the North American Spinal Cord Injury Consortium (NASCIC) to develop a survey of individuals with spinal cord injury. "As researchers, we want to develop effective ways to improve bladder and bowel control, but we need to better understand how bladder and bowel dysfunction affects the people living with it and what would really help them," said Dr. Dennis Bourbeau from the Cleveland FES Center who led the initiative, "this feedback is critical to informing design and development of clinically relevant technologies." A consumer advisory board of people living with spinal cord injury were assembled independently and provided a person-centered perspective to the study. Together they developed a new survey tool, which asked respondents about methods and challenges of managing their bladder or bowel dysfunction; interference with their daily routines, professional activities, and social activities; to rank the bladder and bowel functions that they would like to have improved or restored. The survey also addressed risks versus benefits related to electrical stimulation approaches, including external and implanted systems. The survey was disseminated in summer 2018 and received responses from almost 400 individuals with SCI. Findings were recently published with open access status in the Journal Spinal Cord and provide key insights that will inform the development of new clinical tools for managing bladder and bowel function.

Respondents reported significant challenges with managing their bladder and bowel during social activities, work activities, and daily living activities. Although it may not be surprising that neurogenic bladder and bowel dysfunction interferes with these activities, these data help quantify how important it is to design solutions that are effective outside the home. Respondents reported problems with frequent incontinence, urinary tract infections, constipation, and other health complications. The top priorities for improving bladder function were emptying their bladder without catheters, followed by maintaining urinary continence. The top priorities for improving bowel function were maintaining fecal continence, followed by having predictability and reduced time required in the bowel routine. Respondents were generally interested in trying nerve stimulation devices to improve their bladder or bowel function. There were some concerns with complications from implanting a device surgically, so non-invasive devices were viewed more positively. There were also several “Aha!” moments as the team developed the survey instrument and poured through the responses. For example, they found that hand function was highly correlated with their ability to transfer to a commode and could predict how they answered many of the survey questions. Another realization was that, although respondents were asked to rank bladder and bowel improvements in order of priority for them, many respondents also wrote in that all of these improvements were important and it was difficult to rank them. It is our hope that researchers, clinicians, and device developers carefully consider these perspectives so that treatments advance with the collective insight of everyone able to contribute.

The importance of advancing effective treatments for neurogenic bladder and bowel has been recognized by government organizations and private foundations. The Craig H. Neilsen Foundation invested over $3.4 million in additional research grants, prioritizing approaches designed to hasten progress in developing therapies to alleviate SCI induced bladder and bowel dysfunction. “Researchers are often unsure of how to best include people with lived SCI experience in guiding their work. This publication is a valuable resource for investigators seeking to understand what is really important to people with SCI,” said Dr. Tracey Wheeler from the Craig H. Neilsen Foundation. Results from this survey were incorporated into a neuromodulation development roadmap for neurogenic bladder and bowel which was also published in the same journal.

Written by: Dennis Bourbeau, Abby Bolon, Graham Creasey, Wei Dai, Bill Fertig, Jennifer French, Tara Jeji, Anita Kaiser, Roman Kouznetsov, Alexander Rabchevsky, Bruno Gallo Santacruz, Jiayang Sun, Karl B Thor, Tracey Wheeler, Jane Wierbicky

Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA. ., Case Western Reserve University, Cleveland, OH, USA., Stanford University, Stanford, CA, USA., United Spinal Association, Virginia Beach, VA, USA., Neurotech Network and Neurotech Reports, St. Petersburg, FL, USA., Ontario Neurotrauma Foundation, Toronto, ON, Canada., Toronto Rehabilitation Institute-University Health Network, Toronto, ON, Canada., SCoBIRC, University of Kentucky, Lexington, KY, USA., Radiometer, Copenhagen, Denmark., Department of Statistics, George Mason University, Fairfax, VA, USA., Dignify Therapeutics Inc., Durham, NC, USA., Craig H. Neilsen Foundation, Encino, CA, USA., United Spinal Association, Kew Gardens, NY, USA.

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