NeuroSAFE-guided robot-assisted radical prostatectomy versus standard RARP: systematic review and meta-analysis of comparative studies

Clinical Snapshot

Key Findings

• P Value: Statistically significant for functional outcomes and surgical margins

• Effect Size: OR 2.00 for erectile function; OR 1.36 for continence; OR 0.73 for positive margins

• Primary Outcome: Erectile function recovery significantly improved with NeuroSAFE

• Nnt Or Sensitivity: Approximately 5-6 patients need NeuroSAFE technique to prevent one case of erectile dysfunction

• Confidence Interval: Erectile function: 95% CI 1.46-2.74; Continence: 95% CI 1.05-1.76; Margins: 95% CI 0.59-0.89

Clinical Application

Requires intraoperative frozen section capability and experienced uropathologist availability Limited availability in regional centres; may require referral to tertiary centres with frozen section capabilities. Cost-effectiveness considerations for PBS coverage of extended operative time Men with prostate cancer suitable for nerve-sparing RARP, particularly intermediate-risk disease

Abstract

Prostate cancer is the most common male malignancy, and although robotic-assisted radical prostatectomy (RARP) is widely used, urinary incontinence and erectile dysfunction remain significant issues. NeuroSAFE, an intraoperative frozen section technique aimed at optimizing nerve preservation without compromising cancer control, is increasingly used, but its overall impact on outcomes remains unclear.To systematically evaluate the effectiveness and safety of the NeuroSAFE technique during RARP, comparing functional recovery and oncologic outcomes with non-NeuroSAFE approaches.This systematic review and meta-analysis followed PRISMA 2020 guidelines and was registered in PROSPERO (CRD420251032774). A comprehensive search of Embase, MEDLINE, and ClinicalTrials.gov (March, 2026) identified studies reporting oncologic and/or functional outcomes in men undergoing RARP with NeuroSAFE. Two reviewer teams independently conducted study selection, data extraction, and risk-of-bias assessment using ROBINS-I tool. Random-effects meta-analyses estimated pooled odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was quantified with the I2 statistic, and publication bias was evaluated using Egger's test.Thirteen studies (2 randomized controlled trials and 11 observational cohorts) comprising 22,183 patients met the inclusion criteria. NeuroSAFE was associated with significantly improved postoperative erectile function (OR 2.00; 95% CI 1.46-2.74) and urinary continence recovery (OR 1.36; 95% CI 1.05-1.76). Positive surgical margins were significantly reduced in the NeuroSAFE group (OR 0.73; 95% CI 0.59-0.89). No differences in biochemical recurrence were observed (OR 0.81; 95% CI 0.43-1.56). Heterogeneity was substantial for some outcomes, and most nonrandomized studies carried a serious risk of bias, which limits causal inference.This systematic review and meta-analysis, including randomized evidence, demonstrates that NeuroSAFE is a safe and effective intraoperative strategy that is associated with improved erectile function, enhanced continence recovery, and negative surgical margins without compromising oncologic outcomes. These findings support integrating NeuroSAFE into surgical decision-making for patients undergoing RARP, particularly when nerve preservation can be achieved without compromising oncologic outcomes.In this study, we compared a surgical approach that uses real-time analysis during prostate cancer surgery with the standard technique. This method helps surgeons decide how much tissue to preserve while the operation is still ongoing. We found that this approach is safe and may improve recovery of urinary continence and sexual function, while also reducing the risk of leaving cancer behind, without compromising cancer control.

References

1. 1.Suartz, C. V., Micheleto, J. P. C., Condotta, B. E., Schumacher, L. B., Galhardo, K. A., Azevedo, M. F. D., Brito, P. H. S., Chade, D., Mota, J. M., Dener, M. C., Talizin, T. B., Sharour, W., Shabana, W., Lopes, R. I., Wettstein, M., Elkoushy, M., Nahas, W. C., Melão, B. V. L. A., de Almeida Luz, M., Reis, L. O., de Bessa Junior, J., De Carvalho Fernandes, R., & Filho, L. A. R. (2026). NeuroSAFE-guided robot-assisted radical prostatectomy versus standard RARP: systematic review and meta-analysis of comparative studies. Journal of Robotic Surgery. https://doi.org/10.1016/j.clinsp.2025.100636