NeoTract Announces Publication of Five-Year Results from Pivotal Trial of the UroLift® System
30.6.2017 15:00 | Business Wire
NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced publication of the five-year results of the company’s pivotal, randomized L.I.F.T. IDE study in the Canadian Journal of Urology. The study evaluated the safety and effectiveness of the company’s novel UroLift® System as a treatment for patients with symptomatic benign prostatic hyperplasia (BPH), or enlarged prostate.
In the publication, the authors conclude that the five-year results from the study demonstrate that the UroLift System “has reached maturity as a standard of care for BPH.”
“These results demonstrate both the clinical advantages of the minimally invasive UroLift System as well as its definitive five-year durability,” said Claus Roehrborn, M.D., lead author of the study and professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas, who served as co-principal investigator for the L.I.F.T. clinical program. “From the clinician’s perspective, the procedure is easily learned and quickly performed. For men, it can offer a solution with a better risk profile than traditional BPH surgery, the lowest postoperative catheter requirement of any available BPH procedure, significant improvement of symptoms by two weeks, with sustained relief to five years.”
The study’s authors note that BPH is a quality of life disease, and that treatment options focus on improving quality of life. For many men, improving lower urinary symptoms while inadvertently damaging sexual function, causing incontinence, or exposing them to other safety concerns “may not result in a net positive health outcome.” UroLift System treatment, in contrast, “has been demonstrated to be tolerable under local anesthesia in the office setting, to offer rapid recovery and relief typically without the need for postoperative catheter, to provide improvements in symptoms, flow and quality of life through five years, and to uniquely preserve both ejaculatory and erectile function.”
“We’re thrilled about the positive momentum for this treatment, with growing clinical adoption around the world and tens of thousands of men with lives that have been changed for the better,” said Dave Amerson, president and CEO, NeoTract, Inc. “Payors are recognizing the value of the UroLift System as well, as we estimate more than 70 percent of American men with BPH now covered. We look forward to continuing to make a positive impact for men with this extremely common condition.”
Results of the five-year L.I.F.T. study demonstrate that UroLift System treatment provides:
• A highly tolerable, minimally invasive procedural experience;
• Rapid reduction of symptoms after the procedure while preserving sexual function;
• Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 36% and 44% improved from baseline, respectively;
• Quality of life (QoL) score improvement of 50% over five years;
• A durable treatment with a low surgical retreatment rate of 2-3% per year.
The prospective, randomized, sham controlled, blinded study of the safety and effectiveness of the procedure was performed across 19 centers in the United States, Canada and Australia. A total of 430 subjects were assessed, from which 206 were deemed eligible and enrolled between February and December of 2011. Of those assessed for randomization, 23 (5.3%) were excluded for an obstructive median lobe. Subjects were excluded only if it was deemed cystoscopically that lateral lobe distraction would not mitigate obstruction.
The trial participants were men 50 years of age or older, with International Prostate Symptom Scores of 13 or higher. The subjects were followed 5 years and assessed on symptom response (IPSS), quality of life (IPSS QOL and BPH Impact Index, BPHII), peak flow rate (Qmax), sexual function (International Index of Erectile Function, IIEF, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction, MSHQ-EjD) and adverse events.
Nearly 40 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include interrupted sleep and urinary problems, and can cause loss of productivity, depression and decreased quality of life.
Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the alternative has traditionally been surgery that cuts, heats or removes prostate tissue to open the blocked urethra.
About the UroLift System
The FDA-cleared UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at www.UroLift.com.
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com.
for NeoTract, Inc.
Nicole Osmer, 650-454-0504
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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