Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)

Seoul National University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Device: NIM-Eclipse

Study type: Interventional

Funder types: Other

Identifiers

NCT02507427

H-1504-070-664

Details and patient eligibility

About

To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.

Full description

Using NIM-Eclipse monitoring instrument (Medtronic), we will check action potential of cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in real time during robot assisted laparoscopic radical prostatectomy for preservation of erectile function. In this feasibility and protocol setting phase I/II study, we will evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using NIM-Eclipse monitoring instrument.

Enrollment: 30 patients

Sex: Male

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pathologically proven localized prostate cancer (≤cT3a)
• patients to undergo robot-assisted laparoscopic prostatectomy at our center

Exclusion criteria

• prior hormone therapy
• prior radiation treatment on prostate or pelvis
• refused to participate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Nerve monitoring arm

Experimental group

Description:

They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy.

Treatment:

Device: NIM-Eclipse