Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy

Enrolling by invitation · Not applicable

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

In brief

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.

Key facts

Study ID

NCT07724028

Run by

University Medical Centre Ljubljana

People needed

20

Starts

2026-09-01

Expected to finish

2028-08-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• UMC Ljubljana — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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