Urethral lift found safe, efficacious in real-world setting

A study evaluating outcomes of the prostatic urethral lift (PUL; UroLift System) in clinical practice show that the efficacy and safety documented in the selected group of men enrolled in clinical trials is maintained across the broader spectrum of patients who present for treatment of symptomatic BPH in the real-world setting.

The findings from the retrospective chart review were published in the Journal of Endourology (2019; 33:576-84). The analyses included 1,413 consecutive patients who underwent PUL across 14 sites in the United States and Australia. Within the retrospective study cohort, 165 men were in urinary retention at the time of their procedure. The population also encompassed patients with baseline characteristics that would have excluded them from participation in the premarketing clinical trials; ie, age <50 years, prostate volume <30 cc or >80 cc, moderate symptoms (International Prostate Symptom Score <13), and history of prostate cancer.

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Douglas Grier, MD, private practice, Sound Urological Associates, Edmond, WA, is a study co-author and principal investigator. He told Urology Times, “Results from large controlled clinical trials demonstrate the safety and efficacy of PUL for improving symptoms related to BPH. To our knowledge, this is the first report evaluating outcomes with any BPH device technology within a real-world setting. Its results show PUL is a versatile tool that significantly improves symptoms, voiding function, and quality of life for men treated in diverse practice and geographic settings who are typical of those seen with BPH.”

All of the men underwent PUL after the procedure received marketing clearance. Data analyzed included International Prostate Symptom Score (IPSS), quality of life, and maximum urinary flow rate (Qmax) from follow-up after 1, 3, 6, 12, and 24 months.

Among the patients without urinary retention, IPSS improved from baseline by at least 8.1 points throughout follow-up, and mean quality of life score improved by an average of 41% from baseline.

Baseline IPSS was not recorded in men who were in urinary retention at the time they underwent PUL, but their post-procedure IPSS scores were similar to those in the subgroup of non-retention patients. Additional subgroup analyses showed that benefits of PUL were achieved regardless of age, prostate volume (<30 cc vs. ≥30 cc and <80 cc vs. ≥80 cc), site of service (clinic office, hospital, ambulatory surgery center), prior cancer treatment, diabetic status, and body mass index.

Continue to the next page for more.Among men who were not in urinary retention who underwent PUL at a site where placement of a urinary catheter was not standard of care, 84% required no catheter. Considering all men who were not in urinary retention who received a catheter, rates of catheter independence were 90% at 48 hours, 94% at 5 days, and 98% at 1 month. For patients who were in urinary retention at the time of PUL, 60% were catheter-free at day 5 after PUL, 83% at 1 month, and 87% at the end of the study.

The safety review found that patients who had the procedure done in a clinic office experienced fewer side effects and had a lower rate of catheter placement than groups that had the procedure done at another type of service site. A history of treatment for prostate cancer was not associated with an increase in incidence of serious bleeding, incontinence, urinary tract infection, urosepsis, or infection.

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During the available follow-up, 39 men underwent a PUL retreatment and 33 had another surgical intervention for BPH (laser procedure or TURP). A single patient who did not undergo another surgical intervention had the PUL implant removed.

Dr. Grier said that a prospective study is being planned with the aim of trying to better characterize different subgroups of BPH patients to see if the benefits of PUL and the durability of its results vary depending on pretreatment factors, including age, prostate volume, presence of median lobe involvement, prior treatment for prostate cancer, history of transurethral resection of the prostate, or presence of diabetes and other comorbidities.

Dr. Grier is a consultant to NeoTract/Teleflex, as are several of his co-authors. NeoTract/Teleflex provided funding for the study.