Neurovascular Bundle Stimulation During Robot-Assisted Radical Prostatectomy (NVB Stym-RARP)
Selective Electrical Stimulation of the Neurovascular Bundles During Robot-Assisted Radical Prostatectomy for Intraoperative Monitoring of Erectile Function
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Ljubljana, Slovinsko, 1000
- UMC Ljubljana
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Experimental: Selective Neurovascular Bundle Stimulation
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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Safety and technical feasibility of intraoperative selective neurovascular bundle stimulation
Časové okno: During the surgical procedure (intraoperative assessment).
|
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.
|
During the surgical procedure (intraoperative assessment).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Successful acquisition of intraoperative physiological monitoring signals
Časové okno: During surgery
|
Successful recording of physiological responses during selective neurovascular bundle stimulation, including corpus cavernosum electromyography (CC-EMG), penile rigidity, penile temperature, galvanic skin response, and peripheral pulse measurements.
|
During surgery
|
|
Physiological responses to neurovascular bundle stimulation
Časové okno: During surgery (before and after prostate removal)
|
Characterization and comparison of physiological responses elicited by selective neurovascular bundle stimulation before and after prostate removal.
|
During surgery (before and after prostate removal)
|
|
Investigational device performance
Časové okno: During surgery
|
Evaluation of successful deployment, positioning, stimulation, signal acquisition, and removal of the stimulation probe without device malfunction or procedural failure.
|
During surgery
|
|
Recovery of erectile function
Časové okno: 3, 6, and 12 months after surgery
|
Recovery of erectile function assessed using the International Index of Erectile Function (IIEF) questionnaire or another validated patient-reported outcome measure.
|
3, 6, and 12 months after surgery
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- lokalizovaný karcinom prostaty
- roboticky asistovaná radikální prostatektomie
- stimulace periferních nervů
- Standartní péče
- neurovaskulární funkce
- unilateral or bilateral nerve-sparing surgery
- neurovascular bundles
- prostate removal
- intraoperative selective biphasic charge-balanced electrical stimulation
Další identifikační čísla studie
- 0120-138/2024-2711-6
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .