HTX Urology Practice offering novel BPH treatment as site of FDA-Approved Clinical Study
Trial may help millions of men suffering from enlarged prostate
WEBSTER, Texas, March 15, 2021 /PRNewswire/ -- HTX Urology in Webster, TX (www.htxurology.com) is participating in an FDA cleared research study for a new, minimally invasive device pioneered by Urotronic, Inc., that could dramatically change the way millions of men with enlarged prostates are treated.
Urotronic's Optilume® BPH Catheter System is a simple outpatient procedure that combines balloon dilation to open the prostate and local drug delivery designed to maintain symptom relief. Unlike other BPH procedures, it doesn't cut, burn, laser, steam or leave anything behind in the prostate.
Dr. R. Robert Dhir from HTX Urology said he is "very excited" about the potential of this procedure. "This is a promising solution for many of our patients," Dr. Dhir said. "They will benefit tremendously from its convenience and the fact it's minimally invasive. There's no other treatment option like it out there right now."
Benign Prostatic Hyperplasia (BPH), commonly referred to as an enlarged prostate, affects nearly 40 million American men. Only 12 million men, however, are treated annually for BPH. Many men are unwilling to deal with the side effects of medications or are reluctant to undergo an invasive surgical procedure. Consequently, millions of men are left to deal with the symptoms of BPH including frequent urination, increased frequency of urination at night, an urgent need to urinate, weak stream and straining to urinate.
Dr. Dhir is particularly optimistic about the Optilume BPH Catheter System following a prior clinical study of 80 men who suffered from moderate-to-severe lower urinary tract symptoms caused by BPH. The clinical study found that patient quality of life symptom scores were improved by more than 60% at the 3 month visit and were sustained through 2 year follow-up.
Investigators will monitor the progress of the current clinical trial (PINNACLE), which is now enrolling patients and following them for five years. The FDA will monitor the progress as well.
The Optilume BPH Catheter System is an investigational device, not available for sale in the U.S. CAUTION- Investigational Device. Limited by Federal law to investigational use.
About Urotronic, Inc.
Urotronic, Inc., headquartered in Plymouth, Minnesota, is an early-stage medical device company currently conducting clinical trials to support global commercialization of its products. The Optilume drug-coated balloon technology provides a low-cost, minimally invasive treatment option for men suffering from urinary tract conditions like benign prostatic hyperplasia (BPH) and urethral strictures. The prevalence of BPH and lower urinary tract issues rises markedly with increased age. The drug-coated balloon technology under clinical investigation has the potential to become a paradigm change from the methods currently used by urologists to treat these conditions. For more information on Urotronic and its products, please visit www.urotronic.com.
Contact: Kyle Knauf 763.285.7496
SOURCE Urotronic, Inc.
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