Intra-operative Neuromodulation of the Pelvic Plexus

Prostate Cancer Clinical Trial

Official title:

Intra-operative Neuromodulation of the Pelvic Plexus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03425240
• Other study ID #: 7818
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2018
• Last updated: February 7, 2018
• Start date: September 10, 2014
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Laikon General District Hospital, Athens
• Contact: Spyridon Skoufias, MD
• Phone: spyskouf@hotmail.com
• Email: spyskouf[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Nerve Stimulation
Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.

Locations

Country	Name	City	State
Greece	Laikon General Hospital of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Laikon General District Hospital, Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes
Secondary	Anatomic location of stimulation site	The anatomic location of the stimulation site on the pelvic floor (determined by the surgeon).	5 to 15 minutes
Secondary	Stimulation threshold in volts	Amplitude in volts of the electrical stimulation pulses to induce penile response.	5 to 15 minutes