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

NCT02006927 | Terminated Results DMC FDA Device

• 1 other identifier: 2013-420
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of Nerve Stimulation

  24 months

Study Arms (1)

Nerve Stimulation

EXPERIMENTAL

Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy

Device: Nerve Stimulation

Interventions

Nerve Stimulation DEVICE

Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy

Also known as: Lead stimulation

Nerve Stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kenneth M Peters, MD: lead
• Corewell Health East: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Study was terminated early after technical problems with device caused device removal in all 3 enrolled subjects and withdrawal of all 3 enrolled subjects prior to data collection or analysis.

Results Point of Contact

• Title: Deborah Hasenau, RN
• Organization: William Beaumont Hospitals

deborah.hasenau@beaumont.org

248 551-0804

Study Officials

• Kenneth M Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Urology

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: April 1, 2017
• Last Updated: October 22, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)