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Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy

NCT07724028 · University Medical Centre Ljubljana · Updated 23 July 2026

What is being tested
Selective Neurovascular Bundle Stimulation Probe
For
Histologically Confirmed Localized Prostate Cancer; Scheduled to Undergo Robot-assisted Radical Prostatectomy With Planned Unilateral or Bilateral Nerve-sparing Surgery
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 20 people. The full rules are on the registry page.
Where
Slovenia
When
Starts or started 1 Sept 2026, ends 30 Aug 2028. Registered 23 July 2026.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT07724028

Sites

  • UMC LjubljanaLjubljana, Slovenia