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

Seoul National University Hospital30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

NIM-EclipseDEVICE

Using NIM-Eclipse, nerve monitoring and mapping are performed

Eligibility

Sex: MALEMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Completion rate of nerve monitoring and mapping during RALP

Completion rate of planed surgery without significant intra-operative complication

Time frame: During the operation

Secondary Outcomes

Adverse event

Rate of adverse events during and after procedures upto 12 months

Time frame: 12 months

Quantification of erectile nerve preservation

Changes in action potential after prostate removal from the baseline. Electrical stimulation will be given at each neurovascular bundle 3 times. Action potential will be measured at both corpus cavernosum.

Time frame: During the operation

Correlation between the quantification and subjective nerve preservation grade

Mean value of the quantification by nerve preservation grade (Tewari et al, 2011) which was subjectively scored by the surgeon.

Time frame: During the operation

Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function

Recovery duration of erection measured by the International Index of Erectile Dysfunction(IIEF)-5 score according to the quantification of erectile nerve preservation

Time frame: 12 months

Data from ClinicalTrials.gov

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