Data from 2 years of prospective follow-up in a multinational study show that the prostatic urethral lift (PUL [UroLift System, Neotract, Inc., Pleasanton, CA]) is a safe procedure that provides durable, clinically meaningful improvement of lower urinary tract symptoms due to BPH, reported Claus G. Roehrborn, MD, at the AUA annual meeting in Orlando, FL.
Orlando, FL-Data from 2 years of prospective follow-up in a multinational study show that the prostatic urethral lift (PUL [UroLift System, Neotract, Inc., Pleasanton, CA]) is a safe procedure that provides durable, clinically meaningful improvement of lower urinary tract symptoms due to BPH, reported Claus G. Roehrborn, MD, at the AUA annual meeting in Orlando, FL.
The multicenter study enrolled men aged ≥50 years with an AUA Symptom Index (AUA-SI) score ≥13, a peak flow rate (Qmax) ≥12 mL/s, and prostate volume of 30 cc to 80 cc. They were randomized 2:1 to PUL or a sham procedure. A total of 140 men underwent PUL; 137 were evaluated at 1 month, 123 at 12 months, and 105 at 24 months.
At 1 month, the PUL group had statistically significant improvements from baseline and compared to controls in the AUA-SI, International Prostate Symptom Score quality of life (QoL), and BPH Impact Index (BPH II), and the changes in those endpoints were stable throughout follow-up. Mean changes from baseline to 24 months were –9.2 (–42%) for AUA-SI, –2.2 (–48%) for QoL, and –3.8 (–56%) for BPH II. In addition, mean Qmax was significantly improved (+4.0 mL/sec, +57%), and other collected data showed preservation of sexual function, improved ejaculatory function, and the absence of late safety issues.
Asked where he would see PUL fit into the treatment algorithm for men with BPH, Dr. Roehrborn said certain groups of men would be excluded based on anatomic considerations, but that would still leave about 70% of BPH patients as possible candidates.
“I would not offer this procedure to patients with a substantial intravesical lobe, those without a substantial lateral lobe, or men whose prostate volume exceeds 80 or perhaps 100 cc,” said Dr. Roehrborn, professor and chairman of urology at the University of Texas Southwestern Medical School, Dallas, and co-principal investigator of the pivotal trial program.
“Otherwise, I see PUL as an opportunity for men who have failed medical therapy or even as an alternative to medication.”
He added that forthcoming results from a manufacturer-sponsored trial in Germany comparing PUL with transurethral resection of the prostate (TURP) might provide additional insights on its role.
PUL was approved by the FDA in September 2013. Performed under local anesthesia as an in-office procedure, it involves insertion of small, transprostatic implants through the urethra to compress and hold lateral lobes of the prostate, thereby relieving prostatic urethral obstruction.
In the multicenter study, sexual function was evaluated using the Sexual Health Inventory for Men (SHIM), and during the follow-up to 2 years, there were no significant changes in any of its domains. Ejaculatory function was evaluated using the Male Sexual Health Questionnaire (MSHQ).
“One of our main safety concerns was that the effect of the PUL at the bladder neck might induce ejaculatory problems. However, both the ejaculatory dysfunction score and the bother score of the MSHQ were significantly improved, and there were no de novo cases of sustained erectile or ejaculatory dysfunction,” Dr. Roehrborn said.
The only adverse event that occurred in men followed from 12 to 24 months was a urinary tract infection that was successfully treated. There were no cases of urinary retention.
An additional BPH procedure was performed during the first year after PUL in seven men (5%), and an additional four men required re-intervention between months 12 and 24. Six of the 11 men had another PUL procedure with placement of additional transprostatic devices, and the others underwent laser photoselective vaporization of the prostate or TURP.
Dr. Roehrborn is a consultant/adviser to NeoTract. The study’s co-authors are consultants/advisers, and/or investigators, and/or have an investment interest in Neotract.
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