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

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

Detailed Description
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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.

Official Title
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Safety and Efficacy of Pelvic Autonomic Nerve Monitoring and Mapping During Robot Assisted Laparoscopic Radical Prostatectomy for Preservation of Erectile Function

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: NIM-Eclipse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve monitoring arm<br>They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy. | Device: NIM-Eclipse<br>* Using NIM-Eclipse, nerve monitoring and mapping are performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of nerve monitoring and mapping during RALP | Completion rate of planed surgery without significant intra-operative complication | During the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Rate of adverse events during and after procedures upto 12 months | 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. | 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. | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, robot, nerve mapping and monitoring