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

Stopped early · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02006927

Run by

Kenneth M Peters, MD

People needed

3

Starts

2014-07-01

Expected to finish

2017-04-01

Last updated by the study team

2020-10-22

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Have Peyronies disease.
• Subject possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (eg increases risk, impairs data collection, etc) for the procedure/study.

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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