Prostate Cancer
Conditions
Keywords
Prostate Cancer
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.
Interventions
DEVICENerve Stimulation
Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
Sponsors
Corewell Health East
Kenneth M Peters, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Nerve Stimulation | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Nerve Stimulation | 24 months | Explore the potential efficacy of chronic cavernous nerve stimulation on the return of erectile function post radical prostatectomy. Measures to assess efficacy include direct response to stimulation, changes in penile tumescence (girth) and sensory perception. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nerve Stimulation Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Nerve Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 59.3 years STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Tolerability of Nerve Stimulation
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.
Time frame: 6 weeks
Population: All participants withdrawn from study prior to any data collection or analysis. No data analyzed to report.
Secondary
Efficacy of Nerve Stimulation
Explore the potential efficacy of chronic cavernous nerve stimulation on the return of erectile function post radical prostatectomy. Measures to assess efficacy include direct response to stimulation, changes in penile tumescence (girth) and sensory perception.
Time frame: 24 months
Population: All participants withdrawn from study prior to any data collection or analysis. No data analyzed to report.