A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Neural Regeneration and Erectile Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Kenneth M Peters, MD
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Tolerability of Nerve Stimulation
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Kenneth M Peters, MD
Chief of Urology
William Beaumont Hospitals
Eligibility Criteria
Inclusion Criteria
- •Scheduled for a robotic radical prostatectomy procedure with bilateral nerve sparing.
- •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.
- •Without erectile dysfunction treatment in the 12 months prior to radical prostatectomy.
- •Willing to stop phosphodiesterase 5 inhibitor that has only been started prophylactically to promote penile rehabilitation after prostatectomy.
- •Age 40 to 80 years of age.
- •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.
- •An appropriate candidate for the surgical procedure required for this study.
- •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).
- •Capable of reading and understanding patient information materials and giving written informed consent.
Exclusion Criteria
- •Have been diagnosed with vascular insufficiency to any pelvic blood vessels.
- •Have prior surgical implantation of penile prosthesis, or other prior major pelvic surgery.
- •History of significant pelvic trauma.
- •Are current substance abusers including illicit drugs or use narcotics more than 15 days/month.
- •Have a significant psychiatric disorder or under current treatment with antipsychotic or antidepressive medications.
- •Have previously not tolerated an implanted medical device and subsequently required explant of the device for any reason other than device malfunction.
- •Have a condition currently requiring or likely to require the use of MRI or diathermy.
- •Currently have an active implantable device.
- •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.
- •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.
Outcomes
Primary Outcomes
Tolerability of Nerve Stimulation
Time Frame: 6 weeks
Evaluate the safety and tolerability of chronic cavernous nerve stimulation post radical prostatectomy by measuring the incidence of major complications that may include lead removal, infection at the site or painful stimulation requiring lead removal.
Secondary Outcomes
- Efficacy of Nerve Stimulation(24 months)