Peer-Reviewed Publication
World J Urol2026;44(1)August 13, 2026Journal Article
Recalibrating sham-relative superiority thresholds in BPH device trials.
Jennifer Polo1, Andrew Mugglin2, Naeem Bhojani3,4, Kevin Zorn5, Steven Kaplan6, Dean Elterman7,8, Bilal Chughtai9,10
1Department of Urology, Northwell Health, New Hyde Park, NY, USA.
2Paradigm Biostatistics, LLC, Anoka, MN, USA.
3Faculty of Medicine, Universite de Montreal, Montreal, QC, Canada.
4Division of Urology, Department of Surgery, Universite de Montreal Health Center, Montreal, QC, Canada.
5Department of Urology, BPH Canada Prostate Surgical Institute, Montreal, QC, Canada.
6Department of Urology, Ichan School of medicine at Mount Sinai, New York, USA.
7Division of Urology, Department of Surgery, University of Toronto, Toronto, Canada.
8Division of Urology, University Health Network, Toronto, Canada.
9Department of Urology, Northwell Health, New Hyde Park, NY, USA. Bchughtai@northwell.edu.
10Department of Urology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA. Bchughtai@northwell.edu.
Abstract
PURPOSE: Sham-controlled trials of minimally invasive surgical therapies for benign prostatic hyperplasia (BPH) increasingly use early mean change in International Prostate Symptom Score (IPSS) and sham-relative "super-superiority" thresholds as primary efficacy criteria. This article examines how this framework may affect interpretation of device efficacy when sham responses are strong, while emp…
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