Intra-operative Neuromodulation of the Pelvic Plexus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-10

Study Completion Date

2018-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Erectile Dysfunction Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Nerve Stimulation

Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.

Group Type EXPERIMENTAL

Nerve Stimulation

Intervention Type DEVICE

Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.

Interventions

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Nerve Stimulation

Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No