Recruitment

Recruitment Status
Terminated
Estimated Enrollment
10

Inclusion Criteria

Age 40 to 80 years of age.
Willing to stop phosphodiesterase 5 inhibitor that has only been started prophylactically to promote penile rehabilitation after prostatectomy.
An appropriate candidate for the surgical procedure required for this study.
...
Age 40 to 80 years of age.
Willing to stop phosphodiesterase 5 inhibitor that has only been started prophylactically to promote penile rehabilitation after prostatectomy.
An appropriate candidate for the surgical procedure required for this study.
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.
Scheduled for a robotic radical prostatectomy procedure with bilateral nerve sparing.
Capable of reading and understanding patient information materials and giving written informed consent.
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).
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.

Exclusion Criteria

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.
...
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 been diagnosed with vascular insufficiency to any pelvic blood vessels.
Have Peyronies disease.
Have prior surgical implantation of penile prosthesis, or other prior major pelvic surgery.
Have a condition currently requiring or likely to require the use of MRI or diathermy.
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.
History of significant pelvic trauma.
Are current substance abusers including illicit drugs or use narcotics more than 15 days/month.
Have previously not tolerated an implanted medical device and subsequently required explant of the device for any reason other than device malfunction.
Have a significant psychiatric disorder or under current treatment with antipsychotic or antidepressive medications.

Summary

Conditions
Prostate Cancer
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 80 years
Gender
Only males

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 1...

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.

Inclusion Criteria

Age 40 to 80 years of age.
Willing to stop phosphodiesterase 5 inhibitor that has only been started prophylactically to promote penile rehabilitation after prostatectomy.
An appropriate candidate for the surgical procedure required for this study.
...
Age 40 to 80 years of age.
Willing to stop phosphodiesterase 5 inhibitor that has only been started prophylactically to promote penile rehabilitation after prostatectomy.
An appropriate candidate for the surgical procedure required for this study.
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.
Scheduled for a robotic radical prostatectomy procedure with bilateral nerve sparing.
Capable of reading and understanding patient information materials and giving written informed consent.
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).
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.

Exclusion Criteria

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.
...
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 been diagnosed with vascular insufficiency to any pelvic blood vessels.
Have Peyronies disease.
Have prior surgical implantation of penile prosthesis, or other prior major pelvic surgery.
Have a condition currently requiring or likely to require the use of MRI or diathermy.
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.
History of significant pelvic trauma.
Are current substance abusers including illicit drugs or use narcotics more than 15 days/month.
Have previously not tolerated an implanted medical device and subsequently required explant of the device for any reason other than device malfunction.
Have a significant psychiatric disorder or under current treatment with antipsychotic or antidepressive medications.

Tracking Information

NCT #
NCT02006927
Collaborators
William Beaumont Hospitals
Investigators
  • Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
  • Kenneth M Peters, MD William Beaumont Hospitals