EMORY OFFERS NON-INVASIVE PROCEDURE TO IMPROVE QUALITY-OF-LIFE FOR URINARY INCONTINENCE SUFFERERS

A new non-invasive, painless procedure that uses electromagnetic technology is offering the chance for a major improvement in quality of life for the millions of Americans who suffer from urinary incontinence, or loss of bladder control. By creating a pulsating magnetic field, the new procedure induces strong contractions in the pelvic floor to build strength and endurance in muscles that often are weakened by childbirth, surgery, injury or hormonal changes.

Niall Galloway, F.R.C.S.Ed., Emory associate professor of urology, helped develop the new application for electromagnetic technology along with Charles Epstein, M.D., Emory associate professor of neurology and Kent Davey, former faculty member at the Georgia Institute of Technology. Dr. Galloway is using the technology to treat patients at the Emory Continence Center, an outpatient facility located at The Emory Clinic Smyrna near Emory-Adventist Hospital.

Patients undergoing the therapy sit fully clothed on a chair in a doctor's office or clinic for 20 minutes at a time, twice a week for eight weeks. Although the patient feels the muscles tighten as they are exercised, the device is in the chair seat, so it does not touch the skin and there is no pain.

The new device, called the NeocontrolTM system, uses Extracorporeal Magnetic Innervation (EMITx), a new pulsed electromagnetic technology.

Dr. Galloway led a Phase I feasibility study of the Neocontrol system in 1997 and reported results of an ongoing clinical trial at the International Continence Meeting in Monaco earlier this year. Thus far the procedure has been tested incontinence at sites in Chicago, Cleveland, Orlando and Philadelphia in 117 patients with demonstrated stress urinary incontinence.

Dr. Galloway reported that 83% of the patients had significant improvement in their incontinence after eight weeks of treatment, and 52% reported no leakage. While participants ranked their quality of life at approximately 46% at the beginning of the study, after treatment this ranking rose to 76%. Dr. Galloway will present more complete results of the study in November at the annual meeting of the American Urogynecology Society in Washington. The U.S. Food and Drug Administration (FDA) approved the NeocontrolTM device for clinical use in June. It is manufactured and marketed by Neotonus, Inc., an Atlanta-based medical device company.

Stress and urge incontinence are the two most common forms of the disorder. Stress incontinence results in urine leakage when coughing, laughing, jumping or running. Urge incontinence causes a sudden need to urinate that often results in leakage. The conditions have a variety of causes, but the most common is muscle weakness as a result of childbirth, surgery, injury or hormonal changes. Temporary incontinence can be caused by infections or medications.

Incontinence often causes patients to give up social or physical activities, including simple shopping trips. Many incontinence sufferers avoid seeking medical help because of embarrassment or fear of treatment and try to control their condition by using absorbent pads or catheters.

Eighty-five percent of those affected by the problem are women. The incidence of incontinence increases with age, with almost 40% of women over the age of 65 experiencing episodes. With the large number of baby boomer women nearing menopause, urinary incontinence is a growing health problem.

Although other new medications and devices have been introduced to treat incontinence, most are inconvenient, uncomfortable and require ongoing patient compliance. Kegel exercises, which often are recommended following childbirth, can be helpful in strengthening pelvic floor muscles, but require motivation and long-term

perseverance. Invasive stimulation treatments often are painful and only moderately successful. Although surgery is often effective, it has associated risks and the longterm results are sometimes disappointing.

The electromagnetic fields produced in the NeocontrolTM therapy penetrate the soft tissue of the perineum and stimulate the nerves and muscles of the pelvic floor and

sphincter muscles. The frequency and strength of contractions can be set to the specifications of the physician for each patient.

"NeocontrolTM should be the first step in treating women with mild to moderate stress or urge incontinence," said Dr. Galloway. "While it may not be effective in all cases, our current research shows that many women are completely dry after eight weeks of treatment, and a majority have shown marked improvement in their quality of life."