NCT07724028Enrolling by invitation
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 · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Prostate cancer
- NCT number
- NCT07724028
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Sept 2026 to the primary completion date, 30 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- nerve-sparing surgery is not indicated;
- previous radical prostatectomy or pelvic surgery likely to alter neurovascular bundle anatomy;
Other illness
- 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.
Other
- severe pre-existing erectile dysfunction, defined as an IIEF score ≤20;
- contraindication to robot-assisted radical prostatectomy;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMC Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.