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

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

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve Stimulation; Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy	Device: Nerve Stimulation; Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy; Other Names: Lead stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Collaborators and Investigators

• Sponsor: Kenneth M Peters, MD
• Collaborators: William Beaumont Hospitals
• Investigators: Principal Investigator: Kenneth M Peters, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2013-420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No