Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy | NCT07724028

NCT07724028

Overview

NCT ID: NCT07724028
Lead Sponsor: University Medical Centre LjubljanaOTHER
Official Title: Selective Electrical Stimulation of the Neurovascular Bundles During Robot-Assisted Radical Prostatectomy for Intraoperative Monitoring of Erectile Function
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.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.