Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03721029
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander Nolsøe, Herlev and Gentofte Hospital

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.

Condition or disease Intervention/treatment Phase
Humans Urinary Incontinence Male Urogenital Diseases Prostatectomy Erectile Dysfunction Device: Intraoperative nerve monitoring, Procedure: standard of care robotic-assisted radical prostatectomy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Intraoperative nerve monitoring
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,
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.

Active Comparator: Control Cohort
Patients that undergo standard of care robotic-assisted radical prostatectomy.
Procedure: standard of care robotic-assisted radical prostatectomy
With out the usage of intraoperative nerve monitoring




Primary Outcome Measures :
  1. Return of continence following robotic-assisted radical prostatectomy [ Time Frame: 12 months ]

    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.



Secondary Outcome Measures :
  1. Return of erectile function following robotic-assisted radical prostatectomy [ Time Frame: 12 months ]
    Difference in erection rates and sexual activity between the 2 groups after 12 months. Sexual activity defined as yes to the question "Within the last 3 months, have you been sexually active and attempted intercourse?" Erection is defined as a score of at least 17 on the IIEF-5 form and or a score of a least 3 on the EHS form with the use of either no assistance phosphodiesterase 5 inhibitors

  2. Nerve function prior to removal of the prostate correlated to patient's preoperative urinary function [ Time Frame: 1 day ]
    Correlation between nerve signal prior to removal of the prostate and preoperative urinary function

  3. Nerve function prior to removal of the prostate correlated to patient's preoperative erectile function [ Time Frame: 1 day ]
    Correlation between nerve signal prior to removal of the prostate and preoperative erectile function

  4. Nerve function after removal of the prostate correlated to patient's postoperative urinary function [ Time Frame: 12 months ]
    Correlation between nerve signal after removal of the prostate and postoperative urinary function

  5. Nerve function after removal of the prostate correlated to patient's postoperative erectile function [ Time Frame: 12 months ]
    Correlation between nerve signal after removal of the prostate and postoperative erectile function

  6. Difference in the degree of incontinence between the two groups for incontinent patients. [ Time Frame: 12 months ]
    Measured in gram on the 24-hour pad test

  7. Difference in Time to continence between the two groups [ Time Frame: 12 months ]
    Difference in Time to continence between the two groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721029


Contacts
Layout table for location contacts
Contact: Alexander B Nolsøe, MD +45 38688964 ext +45 20707724 alexander.bjoerneboe.nolsoee@regionh.dk
Contact: Mikkel M Fode, MD, Phd +45 38682093 Mikkel.Mejlgaard.Fode@regionh.dk

Locations
Layout table for location information
Denmark
Herlev and Gentofte Hospital Recruiting
Herlev, Central Region, Denmark, 2730
Contact: Mette schmidt, Adm. officer    +45 38681100    mette.ladefoged.kopp.schmidt@regionh.dk   
Sponsors and Collaborators
Herlev and Gentofte Hospital
Investigators
Layout table for investigator information
Study Director: Jens Sønksen, Dr., Phd, MD Professor

Layout table for additonal information
Responsible Party: Alexander Nolsøe, MD, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT03721029     History of Changes
Other Study ID Numbers: H-6-2013-003
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Alexander Nolsøe, Herlev and Gentofte Hospital:
Urinary incontinence
Prostate cancer
Erectile dysfunction
Functional outcome
Robotic prostatectomy
Prostatectomy
Urethral sphincter

Additional relevant MeSH terms:
Layout table for MeSH terms
Erectile Dysfunction
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological