PLEASANTON and SAN DIEGO, Calif. – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced the presentation of new clinical data from two high quality randomized studies of the company’s novel UroLift® System for patients with Benign Prostatic Hyperplasia (BPH) at the American Urological Association's 2016 Annual Meeting in San Diego.
The presentations included four-year follow-up data from the pivotal, randomized L.I.F.T. IDE study, which evaluated the safety and effectiveness of the UroLift System in subjects with symptomatic BPH and two-year data from the BPH-6 study, which compared the UroLift System with the surgical standard, transurethral resection of the prostate (TURP).
“The clinical data presented at this year’s AUA conference show that treatment with the UroLift system offered men suffering from BPH a well tolerated minimally invasive experience that provided uniquely rapid relief and a durable, sustained effect,” said Dave Amerson, president and CEO, NeoTract, Inc. “We are proud to offer this safe and effective treatment option which can allow men to stop taking BPH medications and be treated with a simple procedure that does not carry the risk of sexual side effects common with other treatment options.”
L.I.F.T. Pivotal Study Four Year Data Shows Sustained Symptom Relief
Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas, presented data from the L.I.F.T. IDE pivotal study, which demonstrated durable improvement in symptoms, quality of life and urinary flow at four years.
“While prior data have shown that this treatment option offers rapid relief with low morbidity, the four year L.I.F.T. study data demonstrate solid durability for a less invasive treatment option,” said Dr. Roerhborn, co-principal investigator for the L.I.F.T. clinical program. “After four years, over 86% of patients were free from seeking additional procedural treatment for BPH.”
The L.I.F.T. IDE Study enrolled 206 patients in a multi-center, randomized, blinded study to evaluate the safety and effectiveness of the UroLift System in patients with symptomatic BPH.
The four-year L.I.F.T. study analysis demonstrated that UroLift system treatment provided:
- Rapid reduction of symptoms with low morbidity, while preserving sexual function;
- Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 41% and 62% improved from baseline, respectively;
- An improved quality of life (QoL), with the QoL score improved 52% over 4 years;
- Freedom from retreatment for most patients, with 9% requiring alternative treatment and 4% requiring additional UroLift implants over the course of 4 years.
BPH-6: UroLift Maintains Superiority over TURP at Two Years
The BPH-6 post-market study is the first-ever randomized comparison between UroLift and TURP, the most common surgical treatment for BPH. The two-year data presented at AUA 2016 demonstrated that the UroLift device continued to respond more consistently than TURP when assessed for overall clinical improvement. This composite BPH6 endpoint defines overall clinical improvement as improved lower urinary tract symptoms (LUTS) without diminished sexual function, continence or safety.
“While TURP is the most common treatment for symptoms caused by an enlarged prostate, the side effects can be significant and may cause men to postpone or refuse treatment altogether,” said Jens Sønksen, M.D., President of the Danish Association of Urology, who presented the data. “The results of this study provided an overall assessment of the ability of UroLift to improve symptoms without compromising important aspects of health, such as sexual function. We were also delighted to see that UroLift demonstrated superior quality of recovery. These characteristics are of great importance to patients when deciding how to address their symptoms.”
The BPH-6 study, a prospective, randomized study, compared the UroLift system treatment to TURP in 80 patients at 10 European centers, with a goal of evaluating the ability of the UroLift System to improve a patient's overall clinical improvement as compared to TURP.
Additional key data points from the study, at two years post-treatment:
- UroLift provided superior quality of recovery and preservation of sexual function as compared to TURP, p<0.01.
- Both UroLift and TURP provided significant symptom relief, quality of life and flow improvement through two years.
- While improvement in International IPSS and Qmax were statistically superior for TURP, this did not result in a difference in quality of life improvement.
- The need for additional treatment, whether for LUTS or complications, was the same between groups, 14% over 2 years.
There are more than 500 million men globally who suffer from BPH, a condition in which the prostate enlarges as men get older. Chronic lower urinary tract symptoms (LUTS) associated with BPH can cause loss of productivity and sleep, depression and decreased quality of life. Medication is often the first line therapy but relief can be inadequate and temporary. Side-effects can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative has been surgery that cuts or heats prostate tissue to open the blocked urethra. Although effective, patients typically only achieve symptom relief after a difficult period of irritative voiding symptoms and wearing a urinary catheter. Even the ‘gold standard’ surgery, TURP (Transurethral Resection of the Prostate), can leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
About the UroLift System
The FDA-cleared UroLift System is a novel, 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, Mexico, South Korea and Canada. 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.UroLift.com or www.NeoTract.com.
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