1.8- Potential complications

What are the Complications From the Treatment?

Digestive System
There have been no digestive system complications reported when AblathermŽ HIFU was used in the initial treatment of T-1 or T-2 cancer of the prostate. In the cases where AblathermŽ HIFU was used in patients with previous radiation treatment failures, there were some reports of mild rectal burning.

Urinary System
Narrowing of the urethra where it passes through the prostate can appear in the months following the treatment due to the scar tissue which normally replaces the treated prostate tissue. This narrowing can necessitate a simple treatment called a transurethral urethrotomy to re-establish the normal urethral channel. A TUR-P may be necessary if the prostate is large enough. Almost all reports of incontinence are mild and can generally be managed with drugs and/or muscle training. Most of the symptoms are resolved in an average of one month.

Complications

Sexual Activity
When sexual impotence occurs, it is usually responsive to pharmocologic treatment (Viagra, Levitra, or Cialis). Following a period of 8 to 12 months after treatment, potency will spontaneously be recovered in many cases.

Summary of AblathermŽ HIFU Complications Reported Throughout the World The chart below describes the complications of using the AblathermŽ HIFU device for treatment as primary care of localized prostate cancer based on experience from around the world:

Death

0%

Digestive complications

0%

Mild to moderate urinary incontinence

8%

Total urinary incontinence

0%

Urethral stenosis

8%

Sexual impotence with nerve-sparing procedure

22%

Sexual impotence without nerve-sparing procedure

66%