Non-Surgical PAE Better Treatment for BPH (benign prostatic hyperplasia)
An enlarged prostate is an unpleasant fact of life for many men, especially as they get older. Worldwide over 200 million men have a clinically significant enlarged prostate gland, the medical condition known as benign prostatic hyperplasia (BPH). At a minimum, an enlarged prostate can ruin sleep and cause discomfort, but left untreated it can also lead to serious medical complications. There are many possible treatments including drugs and surgery, but a new approach – prostatic artery embolization – was demonstrated in a Phase I clinical trial to be minimally invasive and very effective.
The statistics for BPH are somewhat dramatic; in fact, it’s safe to say that as they age nearly all men show signs of an enlarged prostate. The enlargement of the gland, located just under the bladder, begins as early as age 30. By the time they reach 50 nearly half of all men show sign of BPH; by age 80 this number is 75%. For those affected, 40-50% the BPH becomes clinically significant.
As the prostate enlarges, usually through the addition of structural cells (stromal and epithelium), it puts pressure on the urethral canal and affects the discharge of urine. Typically, men with clinical BPH must urinate frequently, often under duress, and especially during the night. As the symptoms increase, there is a greater risk for bladder and urinary tract infection, incontinency, and urinary retention (inability to void the bladder). At some point, many men seek medical intervention. Traditionally this begins with various drug treatments and eventually may lead to surgery. However, the drug treatments are often only partially effective and surgery, while effective, has its own risks.
Research on BPH treatment has been relatively intensive, no surprise given the very large number of potential patients, with most of the attention on pharmaceutical treatment. However, over the last five years a new technique involving radiology developed that held the promise of being minimally invasive – much simpler and less risky than surgery – yet very effective. It’s called prostatic artery embolization and uses laser or radiology to cauterize (burn and close) some of the blood supply (arteries) to the prostate.
In effect, by denying a normal blood supply (though without damaging restriction), the lack of nutrients, oxygen and other blood-borne support, the prostate ceases to enlarge and in most cases begins to shrink.
This result was borne out by a recent Phase I clinical trial conducted in the United States that involved 14 men diagnosed with clinically significant BPH. Each was treated with prostatic artery embolization (PAE), usually in an outpatient setting (less than a day for the treatment). From this group, 13 of the 14 (92%) noted significant reduction in their symptoms within a month. None of them suffered any major complications, such as impotence, leaking urine or infection.
As the lead author of the trial study, Sandeep Bagla M.D. commented, “The participants in our study report a true lifestyle-changing effect after this treatment, with some men stopping medication for their prostate symptoms altogether. Patients who have not been helped by surgery or other laser treatments have benefited. Since the treatment does not involve placing a catheter or device into the penis, there is no risk of narrowing the urethra, incontinence or bleeding.”
The PAE treatment uses existing equipment and does not call for elaborate surgical protocols or support staff, which reduces the time and cost. The next step in the testing of PAE is a Phase IIa clinical trial with 30 men in two groups, one receiving PAE treatment and the other receiving a standard drug treatment.
The timeline for final approval by the U.S. Food and Drug Administration may require two or three more years, but the basics of the PAE treatment and the expected outcomes for safety and effectiveness indicate that this could become one of the better options for men seeking relief from BPH.