%0 Clinical Trial, Phase I
%T Establishment of Novel Intraoperative Monitoring and Mapping Method for the Cavernous Nerve During Robot-assisted Radical Prostatectomy: Results of the Phase I/II, First-in-human, Feasibility Study.
%A Song WH
%A Park JH
%A Tae BS
%A Kim SM
%A Hur M
%A Seo JH
%A Ku JH
%A Kwak C
%A Kim HH
%A Kim K
%A Jeong CW
%J Eur Urol
%V 78
%N 2
%D 08 2020
%M 31103393
%F 24.267
%R 10.1016/j.eururo.2019.04.042
%X Potency preservation often does not meet expectation despite nerve-sparing prostatectomy.<BR>To set the protocol for intraoperative cavernous nerve monitoring and mapping during robot-assisted radical prostatectomy (RARP), and to evaluate its safety and clinical feasibility.<BR>A prospective phase I/II, feasibility study was performed. A total of 30 patients with prostate cancer who underwent RARP at a high-volume tertiary academic hospital were enrolled.<BR>Pudendal somatosensory evoked potential, bulbocavernosus reflex, spontaneous corpus cavernosum electromyography (CC-EMG), median nerve stimulation evoked CC-EMG, and neurovascular bundle (NVB)-triggered CC-EMG with various stimulation protocols were assessed during conventional RARP under total intravenous anesthesia with controlled muscle relaxation.<BR>The primary endpoint was the completion rate of planned surgery and assessment. Adverse events, and erectile and urinary functions were evaluated within 1 yr. CC-EMGs were graded and correlated with functional outcomes.<BR>The completion rate was 100%. Only one patient experienced adverse events, which were not related to study intervention. Grades of CC-EMGs including NVB-triggered CC-EMG before prostate removal were associated with baseline five-item International Index of Erectile Function (IIEF-5) score (grades 0-1, 4.6±2.7; grade 2, 13.2±6.8; grades 3-4, 16.6±5.9; p=0.003). Furthermore, grades of CC-EMGs including NVB-triggered CC-EMG after prostate removal were significantly associated with potency recovery (grade 0, 12.5%; grade 1, 0%; grade 2, 33.3%; grades 3-4, 100% at 12 mo; p=0.005) and postoperative IIEF-5 scores at all evaluation time points (grades 0-1, 2.6±2.8; grade 2, 4.3±5.8; grades 3-4, 15.7±11.0 at 12 mo; p=0.003).<BR>We successfully established the protocol for safe intraoperative cavernous nerve monitoring and mapping using CC-EMG during RARP. Its grades were well correlated with erectile function.<BR>In this first-in-human feasibility study, we successfully established the protocol for safe intraoperative cavernous nerve monitoring and mapping method during robot-assisted radical prostatectomy. The results were significantly associated with erectile function. Evaluation of clinical efficacy to preserve potency seems worthy of further optimization and investigation in confirmatory clinical trials.