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Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy

NCT07724028 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-23

No results posted yet for this study

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

Interventions

DEVICE

Selective Neurovascular Bundle Stimulation Probe

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-08-30
Completion
2028-08-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07724028 on ClinicalTrials.gov