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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03721029
Other study ID # H-6-2013-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2018
Est. completion date June 10, 2022

Study information

Verified date March 2023
Source Herlev and Gentofte Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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.
Procedure:
standard of care robotic-assisted radical prostatectomy
With out the usage of intraoperative nerve monitoring

Locations

Country Name City State
Denmark Herlev and Gentofte Hospital Herlev Central Region

Sponsors (1)

Lead Sponsor Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Return of erectile function following robotic-assisted radical prostatectomy 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 12 months
Secondary Nerve function prior to removal of the prostate correlated to patient's preoperative urinary function Correlation between nerve signal prior to removal of the prostate and preoperative urinary function 1 day
Secondary Nerve function prior to removal of the prostate correlated to patient's preoperative erectile function Correlation between nerve signal prior to removal of the prostate and preoperative erectile function 1 day
Secondary Nerve function after removal of the prostate correlated to patient's postoperative urinary function Correlation between nerve signal after removal of the prostate and postoperative urinary function 12 months
Secondary Nerve function after removal of the prostate correlated to patient's postoperative erectile function Correlation between nerve signal after removal of the prostate and postoperative erectile function 12 months
Secondary Difference in the degree of incontinence between the two groups for incontinent patients. Measured in gram on the 24-hour pad test 12 months
Secondary Difference in Time to continence between the two groups Difference in Time to continence between the two groups 12 months
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