USA – SpineX, Inc., an early stage medtech company has announced that its Spinal Cord Neuromodulator (SCONE) therapy has shown positive results in treating urge urinary incontinence in a first in-human study.
SCONE is a non-invasive transcutaneous spinal cord neuromodulator, developed to treat bladder dysfunction.
The study, conducted by SpineX, demonstrated the effects of the therapy in reducing the symptoms of overactive bladder.
It showed a reduction of 66% in the number of leaks per day along with a 35% reduction in the size of leaks.
The improvements came along with a 6-fold increase in urge-free voids, enhancing the patient’s ability to delay urination until the proper time and place are available.
Urge urinary incontinence is caused by idiopathic overactive bladder affects 12 to 30% of the world’s population with over 33 million individuals in USA living with the condition.
Overactive bladder symptoms include increased urinary urgency, urinary frequency, and urinary incontinence.
These symptoms have profound effect on quality of life, often leading to depression, social isolation, avoidance of physical and sexual activity, loss of productivity, and increased medical expenses.
University of Michigan neurourology and pelvic reconstruction chief Dr. John Stoffel said: “This paper shows that transcutaneous spinal cord neuromodulation is feasible for the treatment of OAB.
“With more data, this could be an exciting development for additional non-invasive treatment options for OAB patients.”
Furthermore, SCONE treatment improved bladder volume feeling significant, providing patients more time to plan their toilet visits.
More significantly, none of the patients had any of the typical adverse effects associated with overactive bladder medication, the study showed.
University of Southern California clinical urology professor Dr. David Ginsberg said: “This study is very exciting. We know OAB has a significant impact on the quality of life of both women and men and we also know that oral medications often are poorly tolerated or do not adequately improve the symptoms seen with OAB.
“This study demonstrates that transcutaneous neuromodulation of the spinal cord with an external device, that does not require implantation, is feasible and improves the bothersome bladder symptoms seen with OAB.”
The study was carried out under the leadership of Dr. Evgeniy Kreydin, MD an assistant professor of urology at University of Southern California and co-founder of SpineX.
In February this year, SpineX announced results of a study that supported the implementation of their SCONE device to deliver non-surgical treatment for activation of bowel function in individuals living with spinal cord injury.
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