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Electrical stimulation of nerves to check erectile function during prostate cancer surgery

Tests a stimulation probe during robot-assisted prostate surgery in 20 men with localized prostate cancer.

Key facts

Who runs it
University Medical Centre Ljubljana
Where
Ljubljana, SloveniaSee the site
Trial code
Registry title
Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy
Status
Enrolling by invitation
People taking part
20 people, planned
Started
1 Sept 2026
Expected to end
30 Aug 2028
Type of study
Interventional
Treatments tested
  • Selective Neurovascular Bundle Stimulation Probe
Record updated
23 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with localized prostate cancer who will have robot-assisted prostate removal with nerve-sparing surgery and who have normal erectile function before surgery.

Age
18 years or older
Sex
Men only
Disease stage
Localized prostate cancer, confirmed by tissue examination, with robot-assisted radical prostatectomy planned with unilateral or bilateral nerve-sparing surgery.
Earlier treatment
No previous radical prostatectomy or pelvic surgery that is likely to change the anatomy of the neurovascular bundles.
Biomarker or test result
Normal erectile function before surgery: International Index of Erectile Function (IIEF) score above 20.

Main reasons for not taking part

  • Nerve-sparing surgery is not indicated
  • Previous radical prostatectomy or pelvic surgery likely to alter neurovascular bundle anatomy
  • Severe erectile dysfunction before surgery (IIEF score 20 or lower)
  • A reason that robot-assisted radical prostatectomy cannot be done
  • Any other condition that the investigator thinks could risk safety or affect the study results

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • nerve-sparing surgery is not indicated
  • previous radical prostatectomy or pelvic surgery likely to alter neurovascular bundle anatomy
  • 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
  • severe pre-existing erectile dysfunction, defined as an IIEF score ≤20
  • contraindication to robot-assisted radical prostatectomy

Where in Slovenia

  • UMC LjubljanaLjubljana, SloveniaNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Experimental: Selective Neurovascular Bundle StimulationTreatment being tested

    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.

    Treatment: Selective Neurovascular Bundle Stimulation Probe

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Selective Electrical Stimulation of the Neurovascular Bundles During Robot-Assisted Radical Prostatectomy for Intraoperative Monitoring of Erectile Function
Plain-language title
Electrical stimulation of nerves to check erectile function during prostate cancer surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 July 2026