Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy

Официальное название

Selective Electrical Stimulation of the Neurovascular Bundles During Robot-Assisted Radical Prostatectomy for Intraoperative Monitoring of Erectile Function

Обзор

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.

Подробное описание

Radical prostatectomy is a standard treatment for localized prostate cancer. Although nerve-sparing robot-assisted radical prostatectomy (RARP) improves functional outcomes, postoperative erectile dysfunction remains common because of injury to the cavernous nerves within the neurovascular bundles (NVBs). Currently, surgeons have limited methods for objectively assessing functional nerve integrity during surgery.

This prospective feasibility study investigates selective electrical stimulation of the NVBs as an intraoperative monitoring technique during RARP. The study will enroll 20 adult patients with localized prostate cancer, normal baseline erectile function (IIEF \>20), and planned nerve-sparing surgery.

A custom-designed stimulation probe based on the selective stimulation model described by Pečlin and Rozman will be applied intraoperatively to the left and right NVBs before and after prostate removal. Medical-grade electrodes will deliver biphasic charge-balanced electrical stimulation within established safety limits that avoid neural tissue injury. The probe will be sterilized using electron beam irradiation.

During stimulation, physiological responses including penile rigidity, corpus cavernosum electromyography (CC-EMG), penile temperature, galvanic skin response, peripheral pulse measurements, and ambient temperature will be recorded. These measurements will be analyzed to assess neurovascular function and compare responses before and after prostate removal.

The primary objective is to evaluate the safety and technical feasibility of selective NVB stimulation during RARP. Secondary objectives include characterization of physiological responses to stimulation and assessment of the potential utility of this technique for intraoperative nerve preservation. Results from this pilot study will provide preliminary evidence to support future larger clinical studies evaluating functional outcomes after nerve-sparing prostatectomy.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Safety and technical feasibility of intraoperative selective neurovascular bundle stimulation [Срок оценки: During the surgical procedure (intraoperative assessment).]

Вторичные конечные точки (4)

• Successful acquisition of intraoperative physiological monitoring signals [Срок оценки: During surgery]
• Physiological responses to neurovascular bundle stimulation [Срок оценки: During surgery (before and after prostate removal)]
• Investigational device performance [Срок оценки: During surgery]
• Recovery of erectile function [Срок оценки: 3, 6, and 12 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Словения · 1 центр

• UMC Ljubljana — Ljubljana

Идентификаторы

NCT: NCT07724028 · 0120-138/2024-2711-6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗