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A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function | Clinical Trials | Clareo Health

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A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function

A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Neural Regeneration and Erectile Function

NCT02006927•Kenneth M Peters, MD

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate electrical stimulation of nerves responsible for erectile function after surgery to remove the prostate (prostatectomy). Electrical stimulation of the nerves responsible for erectile function is experimental. The investigators hypothesize that the subjects can tolerate nerve stimulation.

Detailed Description

The objective of the study is to explore the feasibility of using an implantable neurostimulation device/leads post radical robotic prostatectomy as a method for enhancing neural recovery/penile rehabilitation and/or erectile dysfunction treatment. This will be a single center pilot study of up to 10 patients. The leads will be placed and stimulated intraoperatively to assess proper placement and stimulation parameters needed to achieve change in penile length and/or circumference. One week post operatively, the leads will be connected to an external stimulator device and activated. Subjects will be instructed to stimulate each lead by turning on the device each day for up to six weeks. The leads will be removed at six weeks post operative and subjects will be followed for up to two years.

Eligibility

Age

40 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Scheduled for a robotic radical prostatectomy procedure with bilateral nerve sparing.
•2. Sexually functional preoperatively as defined by a Sexual Health Inventory For Men (SHIM) score of greater than 21 at baseline off any phosphodiesterase 5 inhibitors.
•3. Without erectile dysfunction treatment in the 12 months prior to radical prostatectomy.
•4. Willing to stop phosphodiesterase 5 inhibitor that has only been started prophylactically to promote penile rehabilitation after prostatectomy.
•5. Age 40 to 80 years of age.
•6. Stable on all medications for at least 6 weeks prior to completing baseline measures and be willing to remain on those medications with no dose adjustments expected for 6 weeks post-implantation.
•7. An appropriate candidate for the surgical procedure required for this study.
•8. Willing and able to comply with all study related procedures and visits, and making accurate daily entries into a diary for approximately 6 weeks post radical prostatectomy (lead stimulation phase).
•9. Capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria

•1. Have been diagnosed with vascular insufficiency to any pelvic blood vessels.
•2. Have prior surgical implantation of penile prosthesis, or other prior major pelvic surgery.
•3. History of significant pelvic trauma.
•4. Are current substance abusers including illicit drugs or use narcotics more than 15 days/month.
•5. Have a significant psychiatric disorder or under current treatment with antipsychotic or antidepressive medications.
•6. Have previously not tolerated an implanted medical device and subsequently required explant of the device for any reason other than device malfunction.
•7. Have a condition currently requiring or likely to require the use of MRI or diathermy.
•8. Currently have an active implantable device.
•9. Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months.
•10. Have metabolic or immunodeficiency disorders related to recurrent infections, specifically including but not limited to diabetes mellitus, HIV, disorders requiring chronic or high dose corticosteroids, or connective tissue disorders.
+2 more criteria

Locations (1)

William Beaumont Hospital

Royal Oak, Michigan, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

May 1, 2015

Completion Date

April 1, 2017

Last Updated

October 22, 2020

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Nerve Stimulation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function

Inclusion Criteria

Exclusion Criteria

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