Erectile dysfunction remains a major morbidity after radical prostatectomy. The SAFE technique uses real-time, micro-ultrasound-guided low-pressure hydrodissection to enable atraumatic nerve sparing.
We compared functional and oncologic outcomes of SAFE versus standard robotic-assisted radical prostatectomy (RARP).
In this randomized trial, patients were assigned 1:1 to micro-ultrasound-guided SAFE-RARP or standard RARP. Surgeons were unblinded; patients and outcome assessors were blinded.
The primary endpoint was erectile function recovery at 6 mo (SHIM ≥17), with secondary functional and oncologic outcomes. The primary endpoint was assessed at the prespecified interim analysis using a one-sided pooled z-test within a group-sequential O'Brien-Fleming α-spending framework (interim efficacy boundary, one-sided p < 0.002).
A total of 107 patients were analyzed (SAFE, n = 54; control, n = 53). At 6 mo, erectile function recovery was higher with SAFE than with standard RARP (52% vs 43%; absolute difference 8.5%, 95% CI -10% to 27%; one-sided p = 0.22), without crossing the prespecified interim efficacy boundary. At 6 weeks, early recovery rates were higher with SAFE (37% vs 21%; one-sided p = 0.032), with a smaller difference at 3 mo. Linear mixed-effects modeling showed earlier improvement in SHIM with SAFE, with convergence by 6 mo. Continence, oncologic outcomes, and complication rates were similar between groups. Limitations include the prespecified interim nature of the analysis, the relatively small sample size, and the need for longer follow-up to determine the durability and clinical significance of functional differences.
In this prespecified interim analysis, the primary endpoint of 6-mo recovery was not met. Exploratory analyses suggested earlier postoperative recovery with SAFE, without evidence of compromised safety or oncologic outcomes; these findings are hypothesis-generating.
European urology oncology. 2026 Aug 08 [Epub ahead of print]
Adriana M Pedraza, Monali Fatterpekar, Himanshu Joshi, Manish Choudhary, Coskun Kacagan, Asher Mandel, Chahat Arora, Neeraja Tillu, Murilo De Almeida Luz, Cristina Pasat-Karasik, Ashutosh Maheshwari, Raghav Gupta, Mani Menon, Ashutosh K Tewari
Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA. Electronic address: ., Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA., Department of Population Health Science and Policy, Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.