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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Device: NIM-Eclipse

• Registration Number: NCT02507427
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Study Start: 2015-07-26
• Primary Completion: 2017-03-19
• Study Completion: 2018-03-19
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Completion rate of nerve monitoring and mapping during RALP	During the operation	Completion rate of planed surgery without significant intra-operative complication

Secondary Outcome Measures

Name	Time	Method
Quantification of erectile nerve preservation	During the operation	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.
Correlation between the quantification and subjective nerve preservation grade	During the operation	Mean value of the quantification by nerve preservation grade (Tewari et al, 2011) which was subjectively scored by the surgeon.
Adverse event	12 months	Rate of adverse events during and after procedures upto 12 months
Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function	12 months	Recovery duration of erection measured by the International Index of Erectile Dysfunction(IIEF)-5 score according to the quantification of erectile nerve preservation

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of