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

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 in the treatment group and up to 10 patients
in the control group for a total of 20 patients. For the treatment group, 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.

Patients assigned to the control group will not have the electrical leads implanted during
surgery but will followed with questionnaires and penile sensory and thermal testing at
similar time points.

Inclusion Criteria:

1. Scheduled for a robotic radical prostatectomy procedure with bilateral nerve sparing.

2. Sexually functional preoperatively as defined by a 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.

11. Have Peyronies disease.

12. 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.