Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy

NCT07724028 | Enrolling By Invitation

• 1 other identifier: 0120-138/2024-2711-6
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Histologically Confirmed Localized Prostate Cancer; Scheduled to Undergo Robot-assisted Radical Prostatectomy With Planned Unilateral or Bilateral Nerve-sparing Surgery

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During the surgical procedure (intraoperative assessment).

Secondary Outcomes (4)

• Successful acquisition of intraoperative physiological monitoring signals

  During surgery

• Physiological responses to neurovascular bundle stimulation

  During surgery (before and after prostate removal)

• Investigational device performance

  During surgery

• Recovery of erectile function

  3, 6, and 12 months after surgery

Study Arms (1)

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.

Device: Selective Neurovascular Bundle Stimulation Probe

Interventions

Selective Neurovascular Bundle Stimulation Probe DEVICE

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.

Experimental: Selective Neurovascular Bundle Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-06

Locations

SL (1)