search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NIM-Eclipse
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, robot, nerve mapping and monitoring

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nerve monitoring arm

Arm Description

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

Outcomes

Primary Outcome Measures

Completion rate of nerve monitoring and mapping during RALP
Completion rate of planed surgery without significant intra-operative complication

Secondary Outcome Measures

Adverse event
Rate of adverse events during and after procedures upto 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.
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.
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

Full Information

First Posted
July 22, 2015
Last Updated
February 10, 2019
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02507427
Brief Title
Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)
Official Title
Safety and Efficacy of Pelvic Autonomic Nerve Monitoring and Mapping During Robot Assisted Laparoscopic Radical Prostatectomy for Preservation of Erectile Function
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 26, 2015 (Actual)
Primary Completion Date
March 19, 2017 (Actual)
Study Completion Date
March 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, robot, nerve mapping and monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve monitoring arm
Arm Type
Experimental
Arm Description
They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy.
Intervention Type
Device
Intervention Name(s)
NIM-Eclipse
Intervention Description
Using NIM-Eclipse, nerve monitoring and mapping are performed
Primary Outcome Measure Information:
Title
Completion rate of nerve monitoring and mapping during RALP
Description
Completion rate of planed surgery without significant intra-operative complication
Time Frame
During the operation
Secondary Outcome Measure Information:
Title
Adverse event
Description
Rate of adverse events during and after procedures upto 12 months
Time Frame
12 months
Title
Quantification of erectile nerve preservation
Description
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
Title
Correlation between the quantification and subjective nerve preservation grade
Description
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
Title
Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Wook Jeong, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No part of IPD will be shared.

Learn more about this trial

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

We'll reach out to this number within 24 hrs