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HomeCLINICAL TRIALS, STUDIES, DATANeoTract Announces Publication of Five-Year Results from Pivotal Trial of the UroLift®...

NeoTract Announces Publication of Five-Year Results from Pivotal Trial of the UroLift® System

Treatment for BPH Now “Standard of Care” According to Study Investigators; Results Published in Canadian Journal of Urology

NeoTract, Inc., (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.”

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 addresses the results:  “These results demonstrate both the clinical advantages of the minimally invasive UroLift System as well as its definitive five-year durability.” “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,” he added.

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.”

Dave Amerson, president and CEO, NeoTract, Inc.: “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.”  He concluded, “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.”

Note:  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.

Past NeoTract News

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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