Intra-operative Neuromodulation of the Pelvic Plexus
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|ClinicalTrials.gov Identifier: NCT03425240|
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Prostate Cancer||Device: Nerve Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Intra-operative Neuromodulation of the Pelvic Plexus|
|Actual Study Start Date :||September 10, 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Nerve Stimulation
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. [ Time Frame: 5 minutes ]Change in penile circumference [mm] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.
- Anatomic location of stimulation site [ Time Frame: 5 to 15 minutes ]The anatomic location of the stimulation site on the pelvic floor (determined by the surgeon).
- Stimulation threshold in volts [ Time Frame: 5 to 15 minutes ]Amplitude in volts of the electrical stimulation pulses to induce penile response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425240
|Contact: Spyridon Skoufias, MDemail@example.comfirstname.lastname@example.org|
|Laikon General Hospital of Athens||Recruiting|
|Athens, Greece, 11527|
|Contact: Spyridon Skoufias, MD email@example.com firstname.lastname@example.org|
|Principal Investigator:||Ioannis Adamakis, MD||Laikon General Hospital of Athens|
|Study Chair:||Constantinos A. Constantinides, MD||Laikon General Hospital of Athens|