Purpose: To summarize the Society of Interventional Radiology Foundation's Research Consensus Panel development of a research agenda on prostate artery embolization (PAE). Materials and Methods: PAE for the treatment of lower urinary tract symptoms has been shown to be safe and effective in decreasing symptoms and prostate size. Lack of randomized controlled trials (RCTs) on PAE in the United States has prevented inclusion in American Urologic Association guideline recommendations for treatment of lower urinary tract symptoms resulting from benign prostatic hyperplasia. Recognizing the need for well-designed trials, the SIR Foundation funded a Research Consensus Panel to prioritize a research agenda. The panel included interventional radiologists, urologists, SIR Foundation leadership, and industry representatives. The goal of the meeting was to discuss weaknesses with current data and study design for development of US trials to report long-term outcomes data. Results: Final consensus on a research design could not be made because the group was split on 3 research designs: (i) RCT of PAE versus sham with crossover of the sham group. (ii) RCT of PAE versus simple prostatectomy. (iii) RCT of PAE versus holmium laser enucleation of the prostate/thulium laser enucleation of the prostate. The panel recommended a nonindustry-funded registry to obtain real-world data. Conclusions: Level 1 data are required to be included in the American Urologic Association guidelines for treatment of benign prostatic hyperplasia. Because of concerns with all 3 study designs, the panel did not reach a consensus. Further meetings are planned with the panel to select among these research designs.
Bibliographical noteFunding Information:
C.D. receives personal fees from Boston Scientific (Marlborough, Massachusetts), and Merit Medical (South Jordan, Utah). S.W. receives research support from Guerbet (Villepinte, France), Siemens (Munich, Germany), and Instylla (Boston, Massachusetts), and personal fees from Guerbet, Cook Medical (Bloomington, Indiana), and BTG (London, United Kingdom). A.F. received personal fees from Terumo (Shibuya, Japan), Boston Scientific, and Embolx (Sunnyvale, California). A.I. receives grants from Terumo and personal fees from Terumo, Boston Scientific, CrannMed (Galway, Ireland), and Guerbet. L.F. is president of the Society of Interventional Radiology (Fairfax, Virginia). M.S. received personal fees from Merit Medical and BTG, and grant funds from the French Ministry of Health. M.B. is a paid consultant for Boston Scientific and Auris Health (Redwood City, California). R.A. receives personal fees from Embolx and Merit Medical. R.S. receives personal fees from BTG. S.B. receives research grants from SIR, and personal fees from Merit Medical, Terumo, Embolx, Mentice (Gothenburg, Sweden), and Siemens. T.C. receives personal fees from Boston Scientific, Embolx, and Terumo. None of the other authors have identified a conflict of interest.
© 2019 SIR
PubMed: MeSH publication types
- Consensus Development Conference
- Journal Article