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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507427
• Other study ID #: H-1504-070-664
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 26, 2015
• Est. completion date: March 19, 2018

Study information

• Verified date: February 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 19, 2018
• Est. primary completion date: March 19, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• NIM-Eclipse
Using NIM-Eclipse, nerve monitoring and mapping are performed

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of nerve monitoring and mapping during RALP	Completion rate of planed surgery without significant intra-operative complication	During the operation
Secondary	Adverse event	Rate of adverse events during and after procedures upto 12 months	12 months
Secondary	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
Secondary	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
Secondary	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