Complication Rates After Surgery for BPH: Real-World Data

For patients with benign prostatic hyperplasia (BPH), there are several options when to comes to surgical treatment. A comparison of real-world outcomes reveals significant differences in postprocedural complication and re-treatment rates.

The results come from a retrospective analysis of outpatient Medicare and commercial insurance claims for nearly 30,000 men with BPH.

They show that prostatic urethral lift (PUL; UroLift) was associated with the lowest rate of complications. The re-treatment rate with PUL was similar to re-treatment rates with transurethral resection of the prostate (TURP) and GreenLight photo-selective vaporization of the prostate (PVP).

The highest overall rates of complications, adverse events related to complications, and re-treatment occurred with Rezum water vapor therapy.

The new data were reported by Steven Kaplan, MD, from the Mount Sinai School of Medicine and the Mount Sinai Health System, in New York City, in what was described as a "game-changing" abstract session during the European Association of Urology 2021 Annual Meeting (EAU 2021).

"This analysis reveals that the rate of complications ― that is, the postoperative procedures performed during the return visit ― is lowest after prostatic urethral lift," he said.

In addition, retreatment rates, "which I think for most of us are very, very important for how we assess and how we talk to patients in terms of informed decision making, are similar between, PUL, TURP, and GreenLight PVP," he added.

Claims Data vs Clinical Trials

Kaplan and co-author Daniel Rukstalis, MD, from the Prisma Health USC Medical Group, in Columbia, South Carolina, sought to compare real-world outcomes among the four procedure types using claims data rather than clinical trial results.

"A large-scale analysis of real-world data is an optimal method for comparing approved BPH treatments. One of the challenges in looking at pivotal trials is that they're limited to investigators, and definitions can be different between different studies," Kaplan said.

The researchers pulled data from all Medicare and commercial insurance claims from 2015 through 2019 for men who had received a BPH diagnosis and had been treated with either TURP (18,974 patients; average age, 67 years), GreenLight (9894 patients; average age, 67 years), UroLift PUL (4639 patients; average age, 65 years), or Rezum (780 patients; average age, 64 years).

For the purposes of the study, the reseachers defined complication as a postoperative procedure identified by a Current Procedural Terminology (CPT) code or an International Classification of Diseases (ICD) version 9 or 10 code during a return visit in an outpatient setting.

Adverse events were identified by an ICD-9 or -10 code associated with a complication procedure or a "procedure-driving" event.

Surgical re-treatment was any second BPH procedure occurring after the initial index procedure.

Rate of Complications

The analysis showed that the rate of complications over 300 days was lowest for UroLift PUL, at 16.3%, compared with 19.7% for TURP, 21.6% for GreenLight PVP, and 23% for Rezum (P < .0001).

The most common complications were catheterization, re-cystoscopies, and removal of clots.

The cumulative rate of adverse events associated with complications at 300 days' follow-up was similar between TURP (1.6%) and both GreenLight PVP and UroLift PUL (1.7% for each), compared with 2.7% for Rezum (P = .0404).

The surgical treatment rate at 1500 days' follow-up was lowest with TURP (6.3%), followed by UroLift PUL (6.8%), GreenLight PVP (7.0%), and Rezum (9.5%; P = .0025).

These data should help patients with BPH and their physicians to make informed treatment decisions, Kaplan concluded

"Cornerstone of Data-Driven Medicine"

"I think everyone agrees that real-world data are of paramount importance: they are the cornerstone of data-driven medicine nowadays," said invited discussant Christian Gratzke, MD, from the University of Freiburg, Freiburg, Germany.

Gratzke noted that advantages of population-based studies are that they have large, representative sample sizes and they provide insight into the realities of day-to-day patient care. He cautioned that claims can depend on the underlying coding system and the quality of code entry and that coding practice in the outpatient setting may be misleadling.

"What do we expect from BPH treatment? What is the ideal technique?," he asked. "It should be safe and reproducible, lead to optimal deobstruction, have minimal post-op complications, a short length of stay, low re-treatment rate, meet all the patient's expectations, and be cost-effective, and I think we all agree that that's not possible."

Gratzke noted that he was co-author of a systematic review of patient values, preferences, and expectations about the diagnosis and treatment of male lower urinary tract symptoms. In that review, the investigators found that the patients preferred conservative, less risky treatments. Preferences varied according to the severity of baseline symptoms and the risk/benefit profile of a given treatment.

That review also found that men preferred pharmacologic therapies with lower risk for erectile dysfunction and therapies aimed at improving symptoms of urgency and incontinence.

"It needs to be emphasized again and again that patients' preferences need to be evaluated before treatment," Gratzke said.

He also stated that novel minimally invasive surgical therapies are promising but should still be considered investigational.

"I think time will tell over a longer time period what the real re-treatment rates of these novel techniques are," he said.

No funding source for the study was reported. Kaplan is a principal investigator for the medical device company Urotronic. Gratzke has received fees from multiple drug companies.

European Association of Urology 2021 Annual Meeting (EAU 2021): Presented July 9, 2021.

Neil Osterweil, an award-winning medical journalist, is a long-standing and frequent contributor to Medscape.

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