Alcohol Injection for BPH Clinical Trial Initiated
|
|||
|
Medicinal use of direct alcohol injection is not new and, in fact, was
grandfathered onto the market for use in neurolysis when the Food, Drug
and Cosmetic (FD&C) Act was enacted by Congress in 1938. It's also
been successfully used for ablation of tumors. An
explanation of the procedure in a series of video clips is posted here.
Patients interested in the alcohol injection project should call the offices of the Urological Sciences Research Foundation for further information, (310) 838-6347. Enrollment is expected to remain open through June, 2001. Dr. Mark Plante, urology professor at the University of Vermont, works with Dr. Leonard Marks in the cystosopy suite during alcohol ablation of prostate. (click on image for description and larger version of picture)
|
Los
Angeles, CA, March 19, 2001 --- In a press release today from American
Medical Systems, the testing of direct alcohol injection as a treatment
for men with symptomatic prostate enlargement was announced. The first
men in this nationwide multicenter trial were treated in Los Angeles by
Dr. Leonard Marks, Clinical Associate Professor of Urology at UCLA and
Medical Director of Urological Sciences Research Foundation. 
Now
an application to prostate shrinkage for men with symptomatic BPH is being
explored. The rationale for the project is detailed in the pioneering
The early U.S. work of Dr. Joseph Ditrolio has been presented in 1999
at the annual meeting of the American Urological Association and June,
2000 at the International Consultation on BPH in Paris; 
The procedure is done under a brief anesthetic procedure,
generally involving a few minutes of cystoscopy time and a few hours of
hospital stay. The study is being conducted in 13 medical centers across
the U.S., including Stanford University, San Diego Naval Hospital, Columbia
University, The Cleveland Clinic, and The University of Vermont. 
A
key advance in the present study is the use of a specially curved injection
needle that allows more accurate delivery of the alcohol to the lobes
of the prostate. The endoscopic needle, known as the Prostaject, is marketed
exclusively by American Medical Systems of Minnetonka, MN, sponsor of
the trial. The trial is being conducted under an IND (permit to investigate
a new drug) reviewed by the U.S. Food and Drug Administration in January,
2001.
