Clinical Trial for Restoring Bowel and Bladder Function

Image from www.christopherreeve.org

Using a pacemaker to restore bowel and bladder function is not new and we have reported on this technique before.
What is new is this updated procedure does not involve any nerve cutting.

Santa Clara Valley Medical Center is taking part in a clinical trial of a pacemaker for restoring bladder and bowel function after spinal cord injury and currently recruiting participants for the trial.

Dr Graham Creasey who is one of the respected researchers in this field provided the following information.

The pacemaker was developed in Britain and has been approved by the US Food and Drug Administration to stimulate the nerves that cause bladder and bowel contraction to produce bladder emptying without catheters and to improve bowel emptying.

It has usually been combined with cutting the sensory nerves from the bladder and lower bowel to the spinal cord to reduce unwanted bladder and bowel spasms and improve continence. However, cutting these nerves has limited the number of people wanting the pacemaker.

The purpose of this trial is to test the use of the stimulator without cutting nerves. Instead, different patterns of electrical stimulation will be tested, aiming to reduce spasms of the bladder and bowel and the sphincters and improve both emptying and continence without cutting nerves.

Participants will initially undergo urodynamics, in which the bladder is filled with fluid through a catheter while measuring the pressure in the bladder, to confirm that it is capable of contracting. If suitable, they can undergo surgical implantation of wires on the nerves at the base of the spine that supply the bladder and lower bowel, and the wires will be tunneled under the skin to the pacemaker implanted under the skin of the abdomen. The pacemaker has no batteries and is powered and operated by a remote controller handled by the user. Follow-up visits will be arranged to check the function of the pacemaker.

The Principal Investigator of the trial at Santa Clara Valley Medical Center is Dr. Harminder Singh.

People who have had a complete spinal cord injury for at least two years and who are interested in exploring better ways of managing their bladder and bowel are initially invited to contact Arshad Ali by phone at 669-250-9941 or by email at arshad.ali@hhs.sccgov.org