Study: Spinal Cord Neuromodulation Improves Bladder Function in Paralyzed Patients

SpineX Inc. is announcing promising results of its global, multisite trial showing the clinical benefits of SCONE therapy for neurogenic bladder (NB) in paralyzed patients. More than half the study’s participants reported significant improvements in symptoms and additional benefits in bowel and sexual function.

The CONTINENCE study demonstrated a statistically significant improvement in NB symptoms in patients who received SCONE therapy compared to those who received sham treatment. At the end of the 12-week trial, more than 50% of participants receiving SCONE therapy showed a clinically significant response, as measured by a reduction of 10 points or more on the Neurogenic Bladder Symptom Score (NBSS), a key metric of bladder health.

“The results of the SCONE CONTINENCE trial are highly encouraging,” SpineX Co-Founder Dr. V. Reggie Edgerton, Ph.D., said. “Participants not only reported fewer episodes of urinary incontinence but also improvements in bladder sensation, urgency control, and reduced nighttime awakenings. Participants also reported needing fewer catheters throughout the day—a groundbreaking outcome.”

The CONTINENCE trial was a prospective, single-blinded, sham-controlled pivotal study evaluating the safety and effectiveness of SCONE therapy for neurogenic bladder in patients suffering from paralysis due to spinal cord injury, stroke, or multiple sclerosis. The global study was conducted at 13 medical centers in the United States, Canada and India.

SCONE is a non-invasive spinal cord neuromodulation device that targets spinal neurons and addresses the root causes of neurogenic bladder dysfunction. The U.S. Food and Drug Administration (FDA) granted SCONE Breakthrough Device Designation based on promising early clinical data. The clinical data from the CONTINENCE trial will support regulatory submissions to obtain marketing approval.

“Restoring bladder, bowel, and sexual function is a top priority for individuals with paralysis, who have endured a lack of effective therapies for far too long,” SpineX Co-Founder/CEO Parag Gad, Ph.D., stated. “Unfortunately, effective treatment options have remained elusive—until now. At SpineX, we are dedicated to advancing non-invasive neuromodulation technologies that empower people to regain control and live life on their own terms. SCONE therapy marks a transformative step forward in the treatment of neurological conditions—shifting the focus from merely managing symptoms to actively restoring function.”

SpineX Inc. is a clinical-stage bioelectric medtech company pioneering non-invasive spinal neuromodulation therapies. The company is developing SCONE and SCiP, two FDA-designated Breakthrough Devices aimed at treating neurogenic bladder in adults and cerebral palsy in children, respectively. All SpineX Inc. devices and therapies, including SCONE and SCiP, are investigational and not yet available for commercial use.