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BPH Treatment Device Safety in the FDA’s MAUDE Database Using Total Procedural Context: PUL Exhibits the Lowest Complication Rates, WVTT Intermediate, and AQB the Highest
Abstract
Introduction
Medical Device Reports (MDRs) for Benign Prostatic Hyperplasia (BPH) treatment devices in the Federal Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database were evaluated for safety and patient experience outcomes in the context of the total number of procedures performed.
Materials and Methods
MAUDE was searched using the terms “UroLift,” “Rezum,” and “Aquabeam” for entries between January 1, 2019, and December 31, 2022. An independent physician arbitrator adjudicated relevant entries and assigned severity scores using the Gupta and Clavien-Dindo (CD) scales. An independent market model using Medicare data and Current Procedural Terminology (CPT) codes yielded estimates of the total number of Prostatic Urethral Lift (PUL), Water Vapor Thermal Therapy (WVTT), and Aquablation (AQB) procedures performed in the US in 2019, 2020, 2021, and 2022.
Results
PUL was the most frequently performed procedure in all years analyzed. In the first year (2019), 15% of AQB patients experienced a serious post-operative event. The rate of serious events for PUL (2 per 10,000) was significantly lower than AQB (4 per 1,000, p <0.0001) or WVTT (1 per 1,000, p < 0.0001) in 2022. Between 2019 and 2022, the rate of mild to moderate events (CD 1-2) was lowest for PUL (2019: 2.0 per 10,000; 2022: 1.7 per 10,000) compared to WVTT (2019: 5 per 1,000; 2022: 4 per 1,000) and AQB (2019: 5 per 100; 2022: 3 per 1,000).
Discussion
MAUDE surveillance shows that PUL has the lowest complication rate, WVTT is intermediate, and AQB has the highest, even after procedural refinements. These findings emphasize the need for volume-adjusted, real-world data to complement clinical trials in assessing BPH device safety.
Conclusion
The yearly rates of mild, moderate, and severe events recorded during this period are significantly higher for AQB than the minimally invasive surgical therapies analyzed. PUL has the lowest complication rates in the MAUDE database.