Clinical trial · Interventional
Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy
Selective Electrical Stimulation of the Neurovascular Bundles During Robot-Assisted Radical Prostatectomy for Intraoperative Monitoring of Erectile Function
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Histologically Confirmed Localized Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Scheduled to Undergo Robot-assisted Radical Prostatectomy With Planned Unilateral or Bilateral Nerve-sparing Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selective Neurovascular Bundle Stimulation Probe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Selective Neurovascular Bundle Stimulation
- description
- Participants undergoing nerve-sparing robot-assisted radical prostatectomy will receive intraoperative selective electrical stimulation of the left and/or right neurovascular bundles using an investigational stimulation probe. Physiological responses will be recorded before and after prostate removal.
- interventionNames
- Device: Selective Neurovascular Bundle Stimulation Probe
Primary outcomes (1)
- measure
- Safety and technical feasibility of intraoperative selective neurovascular bundle stimulation
- timeFrame
- During the surgical procedure (intraoperative assessment).
- description
- The primary outcome is the safety and technical feasibility of intraoperative selective neurovascular bundle stimulation, assessed during surgery by successful completion of the stimulation procedure without device-related serious adverse events or clinically significant interference with the planned robotic-assisted radical prostatectomy.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available