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.
, Professor and Chair, Department of Urology UT Southwestern Medical Center,
and co-principal investigator for the L.I.F.T. clinical program, presented the study results at the 26
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.