Urethral lift: 5-year data point to procedure’s durability

Author(s):

Analyses of data from 5 years of prospective follow-up in the pivotal trial supporting regulatory approval of the prostatic urethral lift ([PUL] UroLift System, NeoTract) show that the minimally invasive procedure remains safe and provides rapid and durable benefits for men with symptomatic BPH.

That finding was reported by Claus G. Roehrborn, MD, at the European Association of Urology annual congress in London.

Dr. Roehrborn“This is the largest and longest study of PUL, and it is a very high-quality trial that has FDA oversight and independent reviewers assessing the efficacy and safety data. In addition, it had a 5-year retention rate of 74%, which is considerably higher than many prior pivotal studies of minimally invasive surgical therapies for BPH,” said Dr. Roehrborn, professor and chair of urology at the University of Texas Southwestern Medical Center, Dallas.

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“The study results show that PUL delivers a truly minimally invasive patient experience that avoids serious side effects of traditional surgery and is the only procedure for BPH that does not cause sustained sexual dysfunction. Furthermore, the data show that symptom relief and quality of life improvement occur rapidly after PUL, and men can expect that the significant benefits they experience at 1 month will persist for 5 years.

“Given the safety and benefits of PUL and considering the large number of patients for whom pharmaceutical therapy is either insufficient or intolerable due to side effects, cost, or inconvenience, I believe that PUL should be considered an early treatment option for symptomatic BPH.”

LIFT, the pivotal trial of PUL, was a multinational study that randomized 206 men 2:1 to undergo PUL or a sham procedure. Eligible men were aged ≥50 years with an International Prostate Symptom Score (IPSS) ≥13, peak flow rate (Qmax) ≤12 mL/s, and prostate volume 30 cc to 80 cc. Of the 140 men randomized to PUL, 137 were evaluated at 1 month and 104 were available at 5 years.

Next: Retreatment rate 13.6% in PUL group

Compared with baseline, mean IPSS and mean IPSS quality of life scores in the PUL arm improved by 44% and 42%, respectively, at 1 month (p<.001 for both) and by 36% and 50%, respectively, at 5 years (p<.001). Qmax was improved by 3.5 mL/s at 5 years (+44% vs. baseline).

Further underscoring the durability of improvement provided by PUL were data on the surgical retreatment rate, which was only 13.6% (2% to 3% per year) in the PUL group.

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“Looking at the data in other ways, 86% of men did not require another procedure for BPH, and the retreatment rate also compares very favorably with other procedures for BPH,” said Dr. Roehrborn. “For thermally based procedures, the 5-year retreatment rate ranges from 20% to 50%, and the annual retreatment rate for TURP is 1% to 2%.”

Most done under local anesthesia

Dr. Roehrborn also highlighted the minimally invasive nature of the PUL procedure. In LIFT, 99% of the PUL procedures were done under local anesthesia, 68% of men avoided postprocedural catheterization, and men returned to normal activities at an average of 8.6 days. In a follow-on study of men crossed over from the sham arm to PUL, all procedures were done under local anesthesia, 80% of men avoided catheterization, and the average time to return to normal activities was 5.1 days.

“PUL is truly a minimally invasive procedure that can be offered in the office setting, and those features also make it a unique and important treatment option,” Dr. Roehrborn said.

Dr. Roehrborn is an investigator for NeoTract, NxThera, and Procept.