The following article is part of conference coverage from the 2018 American Urological Association meeting in San Francisco. Renal and Urology News’ staff will be reporting live on medical studies conducted by urologists and other specialists who are tops in their field in kidney stones, prostate cancer, kidney cancer, bladder cancer, enlarged prostate, and more. Check back for the latest news from AUA 2018.
SAN FRANCISCO—Prostatic Urethral Lift (PUL) is a safe and effective treatment for obstructive middle prostatic lobes in men with benign prostatic hyperplasia (BPH), a condition for which treatment options historically have been limited, a researcher reported at the American Urologic Association (AUA) 2018 annual meeting.
PUL (UroLift, NeoTract) is a minimally invasive device that pulls back obstructing prostatic lobes pressing on the urethra to improve urine flow. Urolift was cleared by the FDA in September 2013 to treat blocked urine flow in men aged 50 years and older with BPH.
Daniel Rukstalis, MD, Professor of Urology at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, presented the findings of the multicenter prospective MedLift trial, which enrolled 45 men with BPH-related lower urinary tract symptoms at 9 sites. Inclusion criteria included age 50 years or older, AUA Symptom Index (AUASI) of 13 or higher, peak flow rate 12 mL/sec or less, and prostate volume no greater than 80 cc. The study was conducted as an FDA Investigational Device Exemption extension of the LIFT randomized trial, which examined the use of PUL for lateral lobes of the prostate.
Symptoms of patients with median lobe obstruction responded at least as well to PUL at every time point as patients who had the procedure for lateral lobes only. For the middle lobe patients, the AUASI change at 1, 3, 6, and 12 months was at least a 13.5-point improvement and significantly better than baseline at every time point, Dr Rukstalis’s team found. Quality of life score and BPH Impact Index improved by more than 60% and 70%, respectively, at 3, 6, and 12 months. Peak flow rate improvement ranged from 90% to 130% throughout follow-up. At 1 month, 65% of patients reported a score of 80 or more on the Quality of Recovery scale, 80% reported being “much” or “very much better,” and 89% would recommend the procedure.
None of the patients reported new-onset sustained erectile or ejaculatory dysfunction. Erectile function, as measured by the International Index of Erectile Function-5 questionnaire, remained stable and ejaculatory function was significantly improved throughout follow-up, according to the investigators.
The middle lobe is part of the prostate that grows up beneath the bladder neck and either elevates the bladder neck or actually protrudes into the bladder, Dr Rukstalis explained. “All of the treatments for middle lobe are made more difficult because of this protruding tissue into the bladder,” Dr Rukstalis told Renal & Urology News. “Certainly standard transurethral resection tools can resect a middle lobe, but there is real risk of bladder neck perforation and undermining the bladder neck.”
The original LIFT trial focused on the treatment of the lateral lobes. “It was decided at that time that men with middle lobe enlargement were a different group of men and would not be examined in that trial,” Dr Rukstalis related. “So ultimately after that trial was successfully completed, middle lobe became a contraindication for the use of the UroLift. The MedLift trial was then designed as an extension of the original LIFT trial to address the treatment of the middle lobe.”
For the MedLift trial, surgeons treated the lateral lobe in the standard manner and then treated the middle lobe with a new modification of the UroLift procedure that involved manipulating the middle lobe, displacing it to one side or the other of the prostate, and then implanting one of the lift devices to hold it displaced, further opening the bladder neck, he explained.
As with the established UroLift procedure, adverse events associated with middle lobe treatment were mild to moderate and resolved quickly. The improvements in LUTS mirrored, or even exceeded, those observed in the original LIFT trial.
In December of last year, the FDA approved extending the indications for UroLift to include treatment of the middle lobe. In addition, since the original approval of Urolift, FDA approved it for use in men aged 45 and older rather than 50 and older.
Rukstalis D, Grier D, Stroup S, et al. Multi-center prospective study of the prostatic urethral lift for obstructive median lobe: The MedLift study, an extension of the LIFT randomized study. Oral presentation at the American Urological Association 2018 annual meeting in San Francisco, May 18–21. LBA15.