SpineX has revealed that the first patient has been enrolled in a pivotal trial which will evaluate the safety and effectiveness of the company’s SCONE device for the treatment of neurogenic bladder.
This is the first large-scale pivotal trial testing a non-invasive spinal neuromodulation technology for the treatment of neurogenic bladder, say SpineX. The first patient was enrolled at Rancho Research Institute (Downey, USA).
According to a company press release, neurogenic bladder is the most common comorbidity that people suffer after paralysis, and has the largest impact on their quality of life. Surveys suggest that individuals living with paralysis rate improvement in bladder, bowel and sexual function as a higher priority than restoration of ambulation and even resolution of chronic pain.
Evgeniy Kreydin, co-founder of SpineX and assistant professor at the University of Southern California (Los Angeles, USA), said: “For a person in a wheelchair, the inability to walk is the most obvious functional loss, but the impact on quality of life due to neurogenic bladder is unparalleled.”
The SCONE device is designed to treat those with neurogenic bladder who have symptoms such as lost sensation of bladder fullness, low bladder capacity, frequent urination cycles during the day and night, and living with a constant fear of uncontrolled urine leakage.
Parag Gad, chief executive officer of SpineX, added: “The initiation of the SCONE trial is an important milestone in bringing the world’s first non-invasive treatment modality for neurogenic bladder to market. We are committed to transforming bladder management into a catheter free and leak free world.”