PLEASANTON, Calif., May 7, 2013 /PRNewswire/ -- NeoTract, Inc., today announced the successful results of the 206-patient L.I.F.T. IDE Study, a multi-center, randomized, blinded study in patients with Benign Prostatic Hyperplasia (BPH). All primary and secondary endpoints were met and the study results corroborated prior published data on the novel UroLift® System treatment, a minimally invasive procedure to place permanent UroLift implants. Patients receiving the UroLift implants reported rapid symptomatic improvement, increased urinary flow rates, and preserved sexual function. A significant improvement in Quality of Life for patients was also observed.
Dr. Claus Roehrborn, Professor and Chair, Department of Urology UT Southwestern Medical Center, Dallas and co-principal investigator for the L.I.F.T. clinical program, presented the study results at the 26th Annual American Urological Association (AUA) Congress today stating, "The final analysis from the L.I.F.T. study shows an 88% superiority of treatment (n=140) over control (n=66) and a sustained therapeutic effect in the UroLift implanted patients, as demonstrated by an 11 point AUA Symptom Index improvement from baseline to 1 year. Importantly, this symptom relief was obtained from a local anesthesia procedure with minimal adverse effects contributing to more rapid relief versus other surgical procedures. We look forward to offering this to our patients on a broader scale."
Safety analysis (reviewed by an independent data monitoring committee) showed predominantly mild to moderate transurethral side effects (e.g. dysuria, hematuria, urgency) that typically resolved by two weeks. Postoperative catheterization was low with 68% subjects not receiving a catheter and a mean duration of catheter use less than a day. UroLift patients demonstrated a 4 mL/s maximum urinary flow rate improvement that was statistically superior to control. Also, by not chemically altering or surgically damaging the prostate, as with BPH drugs or surgical approaches, a goal of treatment with the UroLift implant is to preserve sexual function while treating lower urinary tract symptoms. There was no occurrence of loss of ejaculatory or erectile function in any study patient.
"The successful completion of the rigorous L.I.F.T. study marks a significant milestone for the UroLift System and NeoTract highlighting the potential this minimally invasive treatment option brings to patients suffering from an enlarged prostate," said Dave Amerson, President and CEO, NeoTract. Inc. "Given its strong therapeutic benefit and safety profile, we believe UroLift will be a first line treatment option for patients with BPH."
About BPH and the UroLift System Treatment
BPH is a common condition afflicting more than 500 million aging men worldwide. 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 is surgery that cuts or heats prostate tissue to open the blocked urethra. Although effective, patients have to 'earn' their symptom relief after a difficult period of irritative voiding symptoms and catheterization. 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).
The UroLift System is designed to open the urethra directly without applying incisions, surgical resection or thermal injury to the prostate. Obstructive prostate lobes are transurethrally pushed aside and small permanent UroLift implants hold the lobes in the retracted position, thus opening the urethra while leaving the prostate intact.
The UroLift System is currently available for sale in Europe, Australia and Canada and is under FDA review.
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent device designed to treat lower urinary tract symptoms (LUTS). Learn more at www.NeoTract.com.
SOURCE NeoTract, Inc.