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Eur Urol. 2019 May 15. pii: S0302-2838(19)30359-8. doi: 10.1016/j.eururo.2019.04.042. [Epub ahead of print]

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.

Author information

1
Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Urology, Pusan National University Yangsan Hospital, Pusan National University Colleage of Medicine, Yangsan, Republic of Korea.
2
Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Urology, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
3
Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Urology, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Republic of Korea.
4
Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
5
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
6
Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
7
Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: keewonkimm.d@gmail.com.
8
Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: drboss@snu.ac.kr.

Abstract

BACKGROUND:

Potency preservation often does not meet expectation despite nerve-sparing prostatectomy.

OBJECTIVE:

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.

DESIGN, SETTING, AND PARTICIPANTS:

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.

SURGICAL PROCEDURE:

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.

MEASUREMENTS:

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.

RESULTS AND LIMITATIONS:

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).

CONCLUSIONS:

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.

PATIENT SUMMARY:

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.

KEYWORDS:

Cavernous nerve; Electromyography; Erectile function; Intraoperative monitoring; Prostatectomy; Robotic surgery

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