United States of America. The Food and Drug Administration has approved an implanted nerve stimulator to treat a serious type of urinary continence in adults, known as “urge” incontinence in which a sudden and uncontrollable loss of urine results from involuntary bladder wall contractions.
Such contractions may result from neurological conditions such as spinal cord injury, stroke, spina bifida or multiple sclerosis, or from other bladder problems. The new device, the Sacral Nerve Stimulation SystemR (Medtronic Inc.), requires major surgery and is intended for use when other less invasive treatment such as drugs and diet modification have failed.
It consists of a pulse generator about the size of a pacemaker which is implanted in the abdominal wall and a wire lead which is attached to the nerves near the sacrum, the large bone at the bottom of the spine. The generator sends tiny electric impulses via the implanted wire to the sacral nerves, which help control the bladder contractions. The device is battery operated, the battery life being 7 to 9 years. When the battery loses power, surgery will be needed to replace it.
Reference: FDA Talk Paper T97-34 dated 29 September 1997.