Histologically Confirmed Localized Prostate CancerNVB Stym-RARPNCT07724028
Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy
A study testing Selective Neurovascular Bundle Stimulation Probe in people with Histologically Confirmed Localized Prostate Cancer and Scheduled to Undergo Robot-assisted Radical Prostatectomy With Planned Unilateral or Bilateral Nerve-sparing Surgery, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
This prospective first-in-human feasibility study will evaluate the safety and feasibility of selective electrical stimulation of the neurovascular bundles (NVBs) during nerve-sparing robot-assisted radical prostatectomy (RARP). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Histologically Confirmed Localized Prostate Cancer, Scheduled to Undergo Robot-assisted Radical Prostatectomy With Planned Unilateral or Bilateral Nerve-sparing Surgery
- What is being tested?
- Selective Neurovascular Bundle Stimulation Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2026to 30 Aug 2028
- Phase
- Interventional
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male participants aged 18 years or older;
- histologically confirmed localized prostate cancer;
- scheduled to undergo robot-assisted radical prostatectomy (RARP) with planned unilateral or bilateral nerve-sparing surgery;
- normal preoperative erectile function, defined as an International Index of Erectile Function (IIEF) score >20;
- able and willing to provide written informed consent.
Who cannot join
- nerve-sparing surgery is not indicated;
- previous radical prostatectomy or pelvic surgery likely to alter neurovascular bundle anatomy;
- severe pre-existing erectile dysfunction, defined as an IIEF score ≤20;
- contraindication to robot-assisted radical prostatectomy;
- any medical, psychiatric, or other condition that, in the opinion of the investigator, could compromise participant safety, interfere with study participation, or affect interpretation of the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Selective Electrical Stimulation of the Neurovascular Bundles During Robot-Assisted Radical Prostatectomy for Intraoperative Monitoring of Erectile Function
This prospective first-in-human feasibility study will evaluate the safety and feasibility of selective electrical stimulation of the neurovascular bundles (NVBs) during nerve-sparing robot-assisted radical prostatectomy (RARP). 20 adult patients with localized prostate cancer, normal preoperative erectile function (IIEF >20), and planned bilateral or unilateral nerve-sparing surgery will be enrolled.
During surgery, a custom stimulation probe will deliver low-intensity electrical stimulation to the neurovascular bundles before and after prostate removal. Physiological responses, including penile rigidity, corpus cavernosum electromyography (CC-EMG), penile temperature, galvanic skin response, peripheral pulse, and other intraoperative signals, will be recorded to assess preservation of neurovascular function. The stimulation parameters remain below established safety thresholds for neural tissue.
The study aims to determine whether selective neurovascular bundle stimulation is a safe and feasible method for intraoperative functional monitoring during RARP and to generate preliminary data for future clinical studies.
Read the detailed description
Radical prostatectomy is a standard treatment for localized prostate cancer. Although nerve-sparing robot-assisted radical prostatectomy (RARP) improves functional outcomes, postoperative erectile dysfunction remains common because of injury to the cavernous nerves within the neurovascular bundles (NVBs). Currently, surgeons have limited methods for objectively assessing functional nerve integrity during surgery.
This prospective feasibility study investigates selective electrical stimulation of the NVBs as an intraoperative monitoring technique during RARP. The study will enroll 20 adult patients with localized prostate cancer, normal baseline erectile function (IIEF >20), and planned nerve-sparing surgery.
A custom-designed stimulation probe based on the selective stimulation model described by Pečlin and Rozman will be applied intraoperatively to the left and right NVBs before and after prostate removal. Medical-grade electrodes will deliver biphasic charge-balanced electrical stimulation within established safety limits that avoid neural tissue injury. The probe will be sterilized using electron beam irradiation.
During stimulation, physiological responses including penile rigidity, corpus cavernosum electromyography (CC-EMG), penile temperature, galvanic skin response, peripheral pulse measurements, and ambient temperature will be recorded. These measurements will be analyzed to assess neurovascular function and compare responses before and after prostate removal.
The primary objective is to evaluate the safety and technical feasibility of selective NVB stimulation during RARP. Secondary objectives include characterization of physiological responses to stimulation and assessment of the potential utility of this technique for intraoperative nerve preservation. Results from this pilot study will provide preliminary evidence to support future larger clinical studies evaluating functional outcomes after nerve-sparing prostatectomy.
- Conditions
- Histologically Confirmed Localized Prostate Cancer, Scheduled to Undergo Robot-assisted Radical Prostatectomy With Planned Unilateral or Bilateral Nerve-sparing Surgery
- Being tested
- Selective Neurovascular Bundle Stimulation Probe
- Keywords
- localized prostate cancer, robot-assisted radical prostatectomy, unilateral or bilateral nerve-sparing surgery, neurovascular bundles, standard-of-care, prostate removal, intraoperative selective biphasic charge-balanced electrical stimulation, peripheral nerve stimulation, neurovascular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Neurovascular Bundle Stimulation ProbeDevice
An investigational sterile stimulation probe will be used to deliver biphasic charge-balanced electrical stimulation to the neurovascular bundles during robot-assisted radical prostatectomy. Stimulation will be performed intraoperatively before and after prostate removal using stimulation parameters that remain below established neural injury thresholds. Physiological responses will be recorded to evaluate neurovascular function.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Selective Neurovascular Bundle Stimulation | Experimental | Participants undergoing nerve-sparing robot-assisted radical prostatectomy will receive intraoperative selective electrical stimulation of the left and/or right neurovascular bundles using an investigational stimulation probe. Physiological responses will be recorded before and after prostate removal. Receives: Device: Selective Neurovascular Bundle Stimulation Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and technical feasibility of intraoperative selective neurovascular bundle stimulation
The primary outcome is the safety and technical feasibility of intraoperative selective neurovascular bundle stimulation, assessed during surgery by successful completion of the stimulation procedure without device-related serious adverse events or clinically significant interference with the planned robotic-assisted radical prostatectomy.
Measured: During the surgical procedure (intraoperative assessment).
Secondary outcomes (4)
Successful acquisition of intraoperative physiological monitoring signals
Successful recording of physiological responses during selective neurovascular bundle stimulation, including corpus cavernosum electromyography (CC-EMG), penile rigidity, penile temperature, galvanic skin response, and peripheral pulse measurements.
Measured: During surgery
Physiological responses to neurovascular bundle stimulation
Characterization and comparison of physiological responses elicited by selective neurovascular bundle stimulation before and after prostate removal.
Measured: During surgery (before and after prostate removal)
Investigational device performance
Evaluation of successful deployment, positioning, stimulation, signal acquisition, and removal of the stimulation probe without device malfunction or procedural failure.
Measured: During surgery
Recovery of erectile function
Recovery of erectile function assessed using the International Index of Erectile Function (IIEF) questionnaire or another validated patient-reported outcome measure.
Measured: 3, 6, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histologically Confirmed Localized Prostate CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, interventional, first-in-human device feasibility study with an anticipated enrollment of 20 participants. The study uses a Single-Group Assignment with no allocation or comparator group and is conducted as an open-label trial. All enrolled participants will undergo standard-of-care nerve-sparing robot-assisted radical prostatectomy. During the procedure, intraoperative selective electrical stimulation of the left and/or right neurovascular bundles will be performed using an investigational sterile stimulation probe before and after prostate removal. The probe delivers biphasic charge-balanced electrical stimulation within established safety limits for peripheral nerve stimulation. Physiological responses will be recorded to assess neurovascular function and evaluate the safety, technical feasibility, and performance of the investigational device.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724028
- Sponsor's protocol ID
- 0120-138/2024-2711-6
- Acronym
- NVB Stym-RARP
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided