It was a highly-anticipated evening on July 11th when noted researchers Dr. Harminder Singh and Dr. Graham Creasey shared their presentation at an SCI Connections meeting in San Jose for an FDA-approved U.S. clinical trial (the only one in the world) involving the use of a device similar to a pacemaker that would be implanted under the skin in the front area of the waist with wires routed under the skin to the base of the spine and implanted on top of the nerves at the S3/S4 levels responsible for one’s bowel and bladder functions (and for males, achieving erection). They demonstrated how the remote-controlled pacemaker stimulates these nerves, getting them to empty the bladder and bowels as well as a male achieving an erection, all without cutting the sensory nerves, a first-of-its-kind procedure.
NOTE FROM NORCAL SCI: you may listen to the recording of the presentation as well as the multimedia presentation HERE.
But before you get too excited, we want to share a few of the high-level requirements and parameters for participating in this trial as it’s not meant for everyone:
You must be at least 22 years old with a Complete ASIA A Spinal Cord Injury at C4 and below. This was set up to keep the study simple.
You must also be at least two years post injury to be eligible.
They’re only recruiting 10 participants for this round and just completed the procedure on their first participant, a 60-year-old female.
Though the trials are being held in California for now, anyone can apply but if they are accepted into the study, while all the study-related expenses will be covered, all the travel and housing expenses will be the participant’s responsibility.
The nerve stimulator has been commercially available in Britain and other countries since 1982 and has been used in thousands of patients with SCI to improve bladder, bowel and sexual function. It was approved by the FDA in 1998 and available in the U.S. for many years before the company that made the device went bankrupt. However, that old approach involved the cutting of sensory nerves to reduce reflex contraction of the bladder. The new clinical trial does not cut any nerves, a remarkable breakthrough.
In a jaw-dropping segment of the presentation, an x-ray video of a bladder emptying through the electrical stimulation was shown. Over the course of several seconds, a full bladder was slowly emptying, ending with a residual amount of urine left. Dr. Creasey estimates that 95% of the bladder would be emptied using this procedure. He also estimated that 2/3 of fecal matter located closest to the rectum will be emptied as we never truly empty out our bowels, even if able-bodied, since the digestive/intestinal tract is very long. As for erections, a video was shown of a flaccid penis becoming erect following the electrical stimulation and Dr. Creasey pointed out that it can stay erect for as long as the person keeps the electrical stimulation on though lengthy erections are not recommended, at which time, the audience burst out with laughter. The time that it took for the sample demonstration of the erection seemed longer but Dr. Creasey maintained that it’s close to a normal rate and pace of an erection developing. For both males and females, this approach does not result in orgasm and/or ejaculation.
As for the pacemaker, it does not use battery and, therefore, unlike a pacemaker for heart, it does not need to be removed for battery replacement. The electrodes are not likely to require replacement though that might vary from one individual to another. Overall, this study is expected to result in a dramatic reduction of urinary infections, autonomic dysreflexia, cost of medical supplies and predicable and increased quality of life.
Dr. Singh is a Clinical Associate Professor of Neurosurgery at Stanford University School of Medicine. He serves as Chief of Neurosurgery at Santa Clara Valley Medical Center in San Jose and is the Director of Neurotrauma. Dr. Creasey has worked in spinal cord injury for over 30 years in Britain and the U.S. and is particularly interested in restoring function by information technology, bioengineering, functional electrical stimulation and stem cells.
TO RECEIVE MORE INFORMATION ABOUT THIS CLINICAL TRIAL’S ENROLLMENT ELIGIBILITY, CONTACT:
Michael Prutton, Clinical Research Associate: email@example.com