HumansNCT03721029
Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy
A study testing Intraoperative nerve monitoring, in people with Humans and Urinary Incontinence, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Humans, Urinary Incontinence, Male Urogenital Diseases
- What is being tested?
- Intraoperative nerve monitoring,
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Nov 2018to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy
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.
Read the 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.
- Conditions
- Humans, Urinary Incontinence, Male Urogenital Diseases, Prostatectomy, Erectile Dysfunction
- Being tested
- Intraoperative nerve monitoring,, standard of care robotic-assisted radical prostatectomy
- Keywords
- Urinary incontinence, Prostate cancer, Erectile dysfunction, Functional outcome, Robotic prostatectomy, Prostatectomy, Urethral sphincter
- Medical subject headings
- Urinary Incontinence, Male Urogenital Diseases, Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
standard of care robotic-assisted radical prostatectomyProcedure or surgery
With out the usage of intraoperative nerve monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Intraoperative nerve monitoring, |
| Control Cohort | Active comparator | Patients that undergo standard of care robotic-assisted radical prostatectomy. Receives: Procedure: standard of care robotic-assisted radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
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
Measured: 12 months
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
Measured: 1 day
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
Measured: 1 day
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
Measured: 12 months
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
Measured: 12 months
Difference in the degree of incontinence between the two groups for incontinent patients.
Measured in gram on the 24-hour pad test
Measured: 12 months
Difference in Time to continence between the two groups
Difference in Time to continence between the two groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start21 Nov 2018
- Primary completion3 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HumansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Nolsøe, Herlev and Gentofte Hospital
- Investigators
- Jens Sønksen, Dr., Phd, MD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721029
- Sponsor's protocol ID
- H-6-2013-003
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2018
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03721029
- Acronym / sponsor ID
- H-6-2013-003
- Conditions
- Humans, Urinary Incontinence, Male Urogenital Diseases, Prostatectomy, Erectile Dysfunction
- Keywords
- Urinary incontinence, Prostate cancer, Erectile dysfunction, Functional outcome, Robotic prostatectomy, Prostatectomy, Urethral sphincter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative nerve monitoring | Experimental | Device: 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 |
| Control Cohort | Active comparator | Procedure: standard of care robotic-assisted radical prostatectomyPatients that undergo standard of care robotic-assisted radical prostatectomy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Incontinence prior to surgery
- Diabetes
- Known neurological disease that can affect urinary/erectile function
- Condition with Pacemaker
- Previous pelvic trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intraoperative nerve monitoring |
| standard of care robotic-assisted radical prostatectomyWith out the usage of intraoperative nerve monitoring | Procedure or surgery | Control Cohort |
Primary outcome
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.
7 secondary outcomes
Return of erectile function following robotic-assisted radical prostatectomy
Time frame: 12 months
Nerve function prior to removal of the prostate correlated to patient's preoperative urinary function
Time frame: 1 day
Nerve function prior to removal of the prostate correlated to patient's preoperative erectile function
Time frame: 1 day
Nerve function after removal of the prostate correlated to patient's postoperative urinary function
Time frame: 12 months
Nerve function after removal of the prostate correlated to patient's postoperative erectile function
Time frame: 12 months
Difference in the degree of incontinence between the two groups for incontinent patients.
Time frame: 12 months
Difference in Time to continence between the two groups
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Sønksen, Dr., Phd, MD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative nerve monitoring, in people with Humans and Urinary Incontinence, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of continence following robotic-assisted radical prostatectomy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.