Clinical trial NCT03425240: Intra-operative Neuromodulation of the Pelvic Plexus
Official title: Intra-operative Neuromodulation of the Pelvic Plexus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Prostate Cancer
Keywords: Erectile Dysfunction
Prostate Cancer
Neuromodulation
Lead sponsor: Laikο General Hospital, Athens
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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.

Primary outcomes:
measure: Penile circumference increase in millimeters.
timeFrame: 5 minutes
Secondary outcomes:
measure: Anatomic location of stimulation site
timeFrame: 5 to 15 minutes
measure: Stimulation threshold in volts
timeFrame: 5 to 15 minutes
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laikon General Hospital of Athens
Study officials:
affiliation: Laikon General Hospital of Athens
name: Ioannis Adamakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laikon General Hospital of Athens
name: Constantinos A. Constantinides, MD
role: STUDY_CHAIR
References: