Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy

NCT03721029 | Completed DMC FDA Device

• 1 other identifier: H-6-2013-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether the use of intraoperative nerve monitoring during robotic-assisted radical prostatectomy (RARP) can predict and improve post-surgery urinary continence and erectile function.

Conditions

Humans; Urinary Incontinence; Male Urogenital Diseases; Prostatectomy; Erectile Dysfunction

Keywords

Urinary incontinence; Prostate cancer; Erectile dysfunction; Functional outcome; Robotic prostatectomy; Prostatectomy; Urethral sphincter

Outcome Measures

Primary Outcomes (1)

• Return of continence following robotic-assisted radical prostatectomy

  Difference in total International consultation on incontinence questionnaire (ICIQ)-score between the 2 groups after a follow-up of 1 year. ICIQ is a self-reported survey and screening tool for incontinence. It consists of 3 questions regarding symptoms in the past 4 week, with an overall 0-21 score, where greater values indicate increased severity. Question 1 scores from 0-5, question 2 scores either 0,2,4 or 6 and question 3 scores from 0-10. Only the total score is evaluated. Furthermore there is 1 self-diagnostic question.

  12 months

Secondary Outcomes (7)

• Return of erectile function following robotic-assisted radical prostatectomy

  12 months

• Nerve function prior to removal of the prostate correlated to patient's preoperative urinary function

  1 day

• Nerve function prior to removal of the prostate correlated to patient's preoperative erectile function

  1 day

• Nerve function after removal of the prostate correlated to patient's postoperative urinary function

  12 months

• Nerve function after removal of the prostate correlated to patient's postoperative erectile function

  12 months

Study Arms (2)

Intraoperative nerve monitoring

EXPERIMENTAL

Patients that undergo robotic-assisted radical prostatectomy with the use intraoperative nerve monitoring, via electromyography, to identify the exact location of the somatic fibers in the pelvic nerves that seem crucial for urinary continence control and erectile function

Device: Intraoperative nerve monitoring,

Control Cohort

ACTIVE COMPARATOR

Patients that undergo standard of care robotic-assisted radical prostatectomy.

Procedure: standard of care robotic-assisted radical prostatectomy

Interventions

Intraoperative nerve monitoring, DEVICE

Intraoperative nerve monitoring, via electromyography, enables real-time identification of the location of the somatic fibers in the pelvic nerves that seem crucial for urinary continence control and erectile function.

Intraoperative nerve monitoring

standard of care robotic-assisted radical prostatectomy PROCEDURE

With out the usage of intraoperative nerve monitoring

Control Cohort

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that are planned to undergo either non-nerve or unilateral nerve sparring surgery.
• Patients that deemed able to understand the protocol and to return for all the required post-treatment follow-up visits.

You may not qualify if:

• Incontinence prior to surgery
• Diabetes
• Known neurological disease that can affect urinary/erectile function
• Condition with Pacemaker
• Previous pelvic trauma
• Previous pelvic surgery including transurethral resection of the prostate
• Previous pelvic radiation therapy

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, Central Region, 2730, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence; Male Urogenital Diseases; Erectile Dysfunction; Prostatic Neoplasms

Interventions

Intraoperative Neurophysiological Monitoring

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Officials

• Jens Sønksen, Dr., Phd, MD

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: November 21, 2018
• Primary Completion: June 3, 2022
• Study Completion: June 10, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

DK (1)