NeoTract announced the successful results of the 206-patient LIFT investigational device exemption study, a multicentre randomised, blinded study in patients with benign prostatic hyperplasia.
According to the results of the study, all primary and secondary endpoints were met and the study results corroborated prior published data on the 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.
Claus Roehrborn, professor and chair, Department of Urology UT Southwestern Medical Center, Dallas, USA, and co-principal investigator for the LIFT clinical programme, presented the study results at the American Urological Association (AUA) Annual Meeting (4–8 May 2013, San Diego, USA). He said: “The final analysis from the LIFT 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 one year. According to the press release, importantly, symptom relief was obtained from a local anaesthesia procedure with minimal adverse effects contributing to more rapid relief vs. other surgical procedures.”
Safety analysis (reviewed by an independent data monitoring committee) showed predominantly mild to moderate transurethral side effects (eg. dysuria, haematuria, urgency) that typically resolved by two weeks. Postoperative catheterisation was low with 68% subjects not receiving a catheter and a mean duration of catheter use less than a day. UroLift patients demonstrated a 4mL/s maximum urinary flow rate improvement that was statistically superior to control. Also, by not chemically altering or surgically damaging the prostate, as with benign prostatic hyperplasia 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.