AUA 2013: ‘Lift’ procedure shows durable improvement in LUTS

May 7, 2013

Men with symptomatic BPH had statistically significant, durable improvement in lower urinary tract symptoms (LUTS) following an office-based, minimally invasive prostatic urethral lift procedure, results of a pivotal randomized trial showed.

Men with symptomatic BPH had statistically significant, durable improvement in lower urinary tract symptoms (LUTS) following an office-based, minimally invasive prostatic urethral lift procedure, results of a pivotal randomized trial showed.

Men randomized to treatment with the prostatic urethral lift (UroLift, NeoTract, Inc., Pleasanton, CA) showed improvement in AUA Symptom Index (AUA SI) that averaged 11.1 at 3 months, almost twice the improvement observed after sham surgery. Maximum urinary flow (Qmax) increased by 4.4 mL/sec after at 3 months and was sustained at 1 year.

“The study met all primary and secondary endpoints,” reported co-principal investigator Claus Roehrborn, MD, of the University of Texas Southwestern Medical Center in Dallas. “The symptom score improved by 10.8, or 48% from baseline, peak flow rate by 4 mL/sec, or 59%, and durability of at least 1 year was established.”

The trial involved men 50 and older who had LUTS related to BPH, associated with an AUA SI ≥13, Qmax ≤12 mL/sec, and prostate volume of 30 to 80 cc. They were randomized to UroLift or sham procedures, and the primary endpoint was change in AUA SI at 3 months.

UroLift treatment involved insertion of permanent implants into the prostate to retract the lobes away from the prostatic urethra. Sham procedures consisted of rigid cystoscopy conducted with a surgical screen in place and use of a biopsy device to mimic sounds associated with the active treatment.

Investigators randomized 206 patients 2:1 to UroLift or sham procedures. Local anesthesia was used in all but one the 169 procedures performed in North America.

The 3-month change in AUA SI averaged 5.9 in the sham group, which was significantly less than the improvement with UroLift (p=.003). AUA SI improvement with the UroLift system averaged 4.1 after 2 weeks, increasing to 11.1 at 3 months and remaining at 10.8 at 12 months. Improvement in Qmax at 3 months persisted to 12 months, when it averaged 4.0 mL/sec.

There was no occurrence of loss of ejaculatory or erectile function in any of the study patients.

Serious adverse events included clot retention requiring hospital admission in one patient and a bladder stone that was not attached to an implant in one patient. Side effects included dysuria, intermittent gross hematuria, and mild to moderate burning.

The UroLift is currently under FDA review.

Dr. Roehrborn serves as a consultant to NeoTract.