New Minimally Invasive Treatment for BPH
September 18, 2013
In September 2013, the U.S. Food and Drug Administration (FDA) approved marketing for the first permanent implant to increase urine flow in men over the age of 50 with BPH. In this minimally invasive procedurecalled the UroLift® system, the physician pulls back and stitches enlarged prostate tissue that is compressing the urethra and causing BPH symptoms.
Prior to marketing approval, the FDA reviewed data from a number of clinical trialsincluding one study that involved 64 men aged 53 to 83, and another involving more than 200 men between 49 and 86 years of age who were treated using the UroLift system. According to the FDA, the procedure was successfully completed in 98 percent of cases and resulted in a 30 percent increase in urine flow, a decrease in BPH symptoms, and an improved quality of life during the 2 years after treatment. UroLift was approved through the FDA's de novo process for low- to moderate-risk medical devices and procedures that aren't similar to another approved device.
About the Procedure
UroLift can be performed under local or general anesthesia, in a doctor’s office or hospital. The urologist inserts a delivery systemrigid sheath, cystoscopethrough the urethra and determines the precise area(s) of prostate tissue to be pulled back. Then, he/she inserts a small needle into the sheath and uses it to stitch the tissue. The number of implants (stitches) varies, depending on the size and shape of the obstructive tissue. Following the procedure, the instruments and delivery system are removed.
Recovery time is usually quick, and temporary catheterizationwhich often is used in other BPH treatment proceduresmay not be necessary. Studies show that this procedure preserves sexual function, and it is not known to cause serious side effects, retrograde ejaculation, or permanent erectile dysfunction.
Minor side effects include:
- Blood in the urine (hematuria)
- Decreased urine flow
- Incomplete emptying of the bladder
- Pain/burning during urination
- Urinary urgency
Source: U.S. Food and Drug Administration (FDA)