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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
Sponsor:
Information provided by (Responsible Party):
Dr. Ioannis Adamakis, Laikο General Hospital, Athens

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Prostate Cancer Device: Nerve Stimulation Not Applicable

Detailed Description:

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.


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. Stimulation threshold in volts [ Time Frame: 5 to 15 minutes ]
    Amplitude in volts of the electrical stimulation pulses to induce penile response.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for open radical prostatectomy procedure under total anesthesia.
  • Age 40 to 75 years old.
  • Able to read and understand patient information materials and willing to sign a written informed consent.

Exclusion Criteria:

  • Have been diagnosed with severe vasculogenic erectile dysfunction.
  • Have a prior history of pelvic surgery, trauma or irradiation therapy.
  • Have a penile prosthesis.
  • Have been diagnosed with neurologic diseases that may negatively impact erectile functions.
  • Currently having an active implantable device (such as a pacemaker).
  • Posses any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study.
  • Inability to provide a fully informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425240


Contacts
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Contact: Spyridon Skoufias, MD spyskouf@hotmail.com spyskouf@hotmail.com

Locations
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Greece
Laikon General Hospital of Athens Recruiting
Athens, Greece, 11527
Contact: Spyridon Skoufias, MD    spyskouf@hotmail.com    spyskouf@hotmail.com   
Sponsors and Collaborators
Laikο General Hospital, Athens
Investigators
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Principal Investigator: Ioannis Adamakis, MD Laikon General Hospital of Athens
Study Chair: Constantinos A. Constantinides, MD Laikon General Hospital of Athens

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Responsible Party: Dr. Ioannis Adamakis, MD, Principal investigator, Laikο General Hospital, Athens
ClinicalTrials.gov Identifier: NCT03425240     History of Changes
Other Study ID Numbers: 7818
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Ioannis Adamakis, Laikο General Hospital, Athens:
Erectile Dysfunction
Prostate Cancer
Neuromodulation

Additional relevant MeSH terms:
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Erectile Dysfunction
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders