Neuromodulation device shows promising efficacy for neurogenic bladder

SCONE neuromodulation therapy demonstrated encouraging efficacy and safety for neurogenic bladder in patients with paralysis due to spinal cord injury (SCI), stroke, or multiple sclerosis (MS), according to findings from the pivotal CONTINENCE trial (NCT05301335) shared by SpineX Inc.¹

Results from the CONTINENCE trial will support regulatory submissions for the SCONE device.

SCONE is an investigational, noninvasive spinal cord neuromodulation device that was granted a breakthrough device designation from the FDA based on early clinical data. According to the company, SCONE is “designed to target spinal neurons and address the root causes of neurogenic bladder dysfunction.”

“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,” said Parag Gad, PhD, cofounder and CEO of SpineX Inc, in the news release.¹ “Unfortunately, effective treatment options have remained elusive—until now. At SpineX, we are dedicated to advancing noninvasive 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.”

Overall, data from the CONTINENCE trial showed that patients who received SCONE therapy demonstrated a statistically significant improvement in neurogenic bladder symptoms compared with those in the control arm. Specifically, at 12 weeks, more than 50% of patients achieved a clinically significant response, defined as a reduction of 10 points or more in the Neurogenic Bladder Symptom Score (NBSS). There were also additional improvements observed in bowel and sexual dysfunction, according to SpineX.

“The results of the SCONE CONTINENCE trial are highly encouraging,” said V. Reggie Edgerton, PhD, cofounder of SpineX Inc and emeritus professor at the University of California, Los Angeles, in the news release.¹ “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.”

In total, the prospective, single-blinded CONTINENCE trial planned to enroll approximately 126 adult patients with neurogenic bladder due to SCI, stroke, or MS.² Participants were enrolled across 13 clinical trials in the US, Canada, and India.

To be eligible for enrollment, patients needed to have symptoms of urinary urgency or increased frequency of micturition/self-catheterization, sterile urine or asymptomatic bacteriuria, and a score greater than 28 on the NBSS survey. Participants also needed to be at least 1 year out from their initial diagnosis of neurogenic lower urinary tract dysfunction at the time of enrollment.

Those included in the trial were randomly assigned 2:1 to receive SCONE neuromodulation therapy or to a control arm. According to SpineX, SCONE neuromodulation therapy “is delivered through comfortable hydrogel electrode pads that are placed on the skin over specific regions of the spinal column.”³

Each session takes about 60 minutes and treatment requires 2 sessions per week for 12 weeks.

The primary outcome for the trial was improvement in NBSS at 12-week follow-up. Secondary outcome measures included improvements in urge urinary incontinence episodes and Patient Global Improvement Index.

According to the company, results from the CONTINENCE trial will be used to support regulatory submissions for marketing approval of the SCONE device.

REFERENCES

1. SpineX Inc. announces significant improvement in urinary bladder function in paralyzed individuals with SCONE Therapy. News release. SpineX Inc. April 15, 2025. Accessed April 16, 2025. https://www.businesswire.com/news/home/20250415929779/en/SpineX-Inc.-Announces-Significant-Improvement-in-Urinary-Bladder-Function-in-Paralyzed-Individuals-with-SCONE-Therapy

2. Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study (CONTINENCE). ClinicalTrials.gov. Last updated February 17, 2025. Accessed April 16, 2025. https://clinicaltrials.gov/study/NCT05301335

3. SCONE. SpineX. Accessed April 16, 2025. https://spinex.co/our-technology/scone/