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Completed

NCT Number: NCT02507427

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIM-Eclipse

Device

Using NIM-Eclipse, nerve monitoring and mapping are performed

Primary outcomes

  1. Completion rate of nerve monitoring and mapping during RALP

    Time frame: During the operation

    Completion rate of planed surgery without significant intra-operative complication

Secondary outcomes

  1. Adverse event

    Time frame: 12 months

    Rate of adverse events during and after procedures upto 12 months

  2. Quantification of erectile nerve preservation

    Time frame: 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.

  3. Correlation between the quantification and subjective nerve preservation grade

    Time frame: During the operation

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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 24, 2015
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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