An interventional study of Nerve Stimulation in Erectile Dysfunction and Prostate Cancer, sponsored by Laikο General Hospital, Athens. Status unknown at 1 site in Greece. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Laikο General Hospital, Athens · Not applicable, Interventional, and Device feasibility
The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).
Prostate cancer is the main cancer in men. However, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (RP), the gold standard treatment for non-metastatic cancers. Unfortunately, despite providing optimal cancer control, RP often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not been able to prove a beneficial action yet. However, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. Therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy.
The primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. During standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded.
The secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Laikο General Hospital, Athens is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.
Device: Nerve Stimulation
Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.
Penile circumference increase in millimeters.
Change in penile circumference \[mm\] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.
Time frame: 5 minutes
Anatomic location of stimulation site
The anatomic location of the stimulation site on the pelvic floor (determined by the surgeon).
Time frame: 5 to 15 minutes
Stimulation threshold in volts
Amplitude in volts of the electrical stimulation pulses to induce penile response.
Time frame: 5 to 15 minutes
Started Sep 2014 (actual). Primary completion is estimated for Dec 2018, 51 months after the start.
Of 115 non-industry interventional studies with no phase under Erectile Dysfunction, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 51 months is above that.
Counting every sponsor, half of 137 studies reached it within 32 months; a quarter within 14 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Laikο General Hospital, Athens