- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03721029
Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy
Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy
Study Overview
Status
Detailed Description
Study design:
This is a single center, randomized, single blinded, prospective, clinical trial. The study population will comprise of 100 men that will undergo either a non-nerve sparring or unilateral-nerve sparring RARP. This means that the preoperative evaluation has suggested that it will not be possible to preserve the cavernous parasympathetic nerves lying in the fascia on either side of the prostate gland during surgery (called bilateral-nerve sparring). Despite the term, non-nerve sparring surgery, the surgeon will still attempt to preserve the somatic fibers of the pudendal nerve as best possible. However, due to the extent of cancer tissue the surgeon will generally need to operate closer to the pudendal nerve then when performing bilateral-nerve sparring surgery. So, the somatic fibers of the pudendal nerve are more likely to be severed. The same is the case on one side when performing unilateral surgery.
The treatment group will consist of 50 subjects that will undergo nerve monitoring during RARP. Results will be compared to a control cohort consisting of 50 patients that will undergo contemporary RARP.
Aside from the usage of nerve monitoring in the intervention-group, all procedures and care from admission to the hospital through discharge will be standard of care for subjects in both the control and Intervention-group.
Baseline evaluation and collection of data:
Patients will be screened for eligibility on the phone, and if eligible and they accept they will be scheduled to a visit at the hospital where the following data will be registered for all participants prior to surgery:
- Age at time of surgery
- Known co-morbidity
- Body Mass Index (BMI)
- Medicine status
- Smoking
- Partner status
- Level of education
- Employment Clinical status
- Clinical stage (cT-staging)
- Gleason score
- Prostate specific antigen (PSA)
Prior to surgery participants will also have answered the questionnaires listed either prior to or during the first visit and have undergone an MRI and the bulbocavernosus-reflex test:
- ICIQ (International Consultation on Incontinence Questionnaire) form about incontinence symptoms
- Danish Prostate Symptom Score (DAN-PSS)
- International Prostate Symptom Score (IPSS)
- International Index of Erectile Function (IIEF) score
- Erection Hardness Scale (EHS) score
- Presence or absence of bulbocavernosus-reflex. The physician test for this by shortly squeezing the penis while observing if the urethra retracts or the anal sphincter contracts. The test is not painful and only takes a few seconds.
- Magnetic Resonance Imaging (MRI) scan with measurements of the urethral length and width, and prostate volume along with other specific anatomical structures in relation to the urethra. Contrast agents will not be applied.
Intraoperative data:
- Contraction of the sphincter musculature during stimulation via the nerve monitoring system before removal of the prostate gland
- Contraction of the sphincter musculature during stimulation via the nerve monitoring system after removal of the prostate gland.
- Blood loss
- Non- or unilateral nerve sparring
- Lymph node dissection
- Total surgical time
- Sphincter lesion
- The surgeon's subjective prediction whether the patient will return to continence postoperatively
During the procedure, through discharge and before follow-up regime begins, the following data points will be collected:
- Time to removal of catheter
- Leakage of the anastomosis
- Stricture.
- Other adverse effects
- Pathologic cancer stage (pT-stage)
- Pathologic Gleason score
- Status of surgical margins
Follow-up evaluation.
Subjects will be evaluated 14 days after catheter removal and at standard clinical controls at 3, 6 and 12 months. The following questionnaires are answered at every visit:
- International consultation on Incontinence Questionnaire (ICIQ) for incontinence,
- Danish Prostate Symptom Score (DAN-PSS)
- International Prostate Symptom Score (IPSS)
- International Index of Erectile Function (IIEF) and Erection Hardness Scale (EHS).
During the last 3 visits subjects also answers a fluid intake/output questionnaire and hand in the results of a 24-hour pad test. In addition to the questionnaires the patients will also undergo an MRI and a bulbocavernosus reflex test 12 months postoperative.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Central Region
-
Herlev, Central Region, Denmark, 2730
- Herlev and Gentofte Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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.
|
With out the usage of intraoperative nerve monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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
|
1 day
|
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
|
1 day
|
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
|
12 months
|
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
|
12 months
|
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
|
12 months
|
Difference in Time to continence between the two groups
Time Frame: 12 months
|
Difference in Time to continence between the two groups
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-6-2013-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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