A large-scale analysis of treatments for benign prostatic hyperplasia (BPH) showed that complications are lowest after the UroLift Prostatic Urethral Lift (PUL) procedure, and real-world retreatment rates are highest for the Rezum steam injection therapy.
While retreatment rates for PUL, transurethral resection of the prostate (TURP), and GreenLight Laser Prostatectomy were comparable over the course of 365 days, the 1-year retreatment hazard was 36%, 40%, and 43% higher for Rezum versus PUL, TURP, and GreenLight, respectively, reported Steven Kaplan, MD, of the Icahn School of Medicine at Mount Sinai in New York City.
“The data from this large scale, real-world analysis, can be utilized to aid patients and providers — and I would say payers — in making informed treatment decisions,” Kaplan said in a presentation at a late-breaking abstract session of the American Urological Association virtual meeting.
This was a patient-level, longitudinal analysis of Medicare and commercial outpatient claims data from 2015 to 2019, from which Kaplan and co-author Daniel Rukstalis, MD, of Prisma Health in Columbia, South Carolina, compiled real-world rates on return procedures and retreatments related to the four BPH treatments. The representative sample included 19,507, 10,173, 5,228, and 935 TURP, GreenLight, PUL, and Rezum procedures, respectively.
Return procedures were defined as as post-operative procedure — such as a cystoscopy or bladder irrigation — performed during a return visit to an outpatient setting, while surgical retreatment was defined as a second BPH procured occurring after the initial index procedure.
The variables adjusted for the Cox proportional hazard model included age, cost of index procedure, comorbidities, adverse events, and the site of service.
At 365 days after the initial procedure, the rate of return procedures was lowest for PUL (17%), followed by TURP (21%), GreenLight (22%), and Rezum (23%).
When evaluating the hazard ratios for return procedures, the authors reported:
- 24% for TURP vs PUL (HR 1.239)
- 35% for GreenLight vs PUL (HR 1.353)
- 41% for Rezum vs PUL (HR 1.411)
When looking at the rate of surgical retreatment, Kaplan and Rukstalis observed that the rates at 1 year were similar between GreenLight (5.2%), TURP (5.3%), and PUL (5.4%), while the rate for Rezum was higher (7.2%).
“This is important,” Kaplan said. “This is the data, not statistical manipulations and projections.”
The hazard model for 1-year retreatment showed that the risk for was 36% higher for Rezum versus PUL (HR 1.361), 40% higher for Rezum versus TURP (HR 1.399), and 43% higher for Rezum versus GreenLight (HR 1.427), according to Kaplan.
“The retreatment rates for TURP, GreenLight, Rezum and PUL all seem to be a little bit higher than previously reported, but the 1-year retreatment rate for PUL is similar to TURP and GreenLight,” he noted. “The retreatment rate at 1 year is clearly highest for Rezum — and those trends were consistent for the 365-day course that we followed.”
Kaplan said the ongoing compilation of more data will provide an even better view of what the retreatment rates are for all these procedures, and “this will help us get a much more realistic view when speaking to our patients in terms of what therapies are out there, and the retreatment rates that we see — not from clinical trials, but from the real world,” he concluded. “And frankly, that’s what matters most.”
Kevin Ginsburg, MD, of Fox Chase Cancer Center in Philadelphia, told MedPage Today that it is important to acknowledge the potential for selection bias as a study limitation.
“We do not have granular details to know the severity of symptoms in each group, or if the severity was comparable at baseline between the groups. Furthermore, we do not have quality of life data to accompany these results,” said Ginsburg, who was not involved in the study. “Nonetheless, these data may help inform patients deciding on which type of surgical treatment to pursue for their BPH, especially if avoiding retreatment is a priority for them.”
Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.
The study was funded by NeoTract/Teleflex.
Kaplan disclosed serving as principal investigator for the Urotonic and ProVerum regulatory trials.
Rukstalis disclosed a relationship with NeoTract/Teleflex.