Intra-operative Neuromodulation of the Pelvic Plexus

Not Applicable

• Conditions: Prostate Cancer; Erectile Dysfunction
• Interventions: Device: Nerve Stimulation

• Registration Number: NCT03425240
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2014-09-10
• Study First Submitted: 2018-01-24
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-07
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nerve Stimulation	Nerve Stimulation	Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.

Primary Outcome Measures

Name	Time	Method
Penile circumference increase in millimeters.	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

Name	Time	Method
Anatomic location of stimulation site	5 to 15 minutes	The anatomic location of the stimulation site on the pelvic floor (determined by the surgeon).
Stimulation threshold in volts	5 to 15 minutes	Amplitude in volts of the electrical stimulation pulses to induce penile response.

Trial Locations

Locations (1)

Laikon General Hospital of Athens; 🇬🇷 Athens, Greece