Prostate CancerNCT02006927
A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function
A study testing Nerve Stimulation in people with Prostate Cancer, run by Kenneth M Peters, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Nerve Stimulation
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve StimulationDevice
Also called Lead stimulation
Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Nerve Stimulation | Experimental | Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy Receives: Device: Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionApr 2017
Why it stopped: Lack of Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth M Peters, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor-investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth M Peters, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006927
- Sponsor's protocol ID
- 2013-420
- Status last verified
- Sep 2020
- First submitted
- 4 Dec 2013
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Neural Regeneration and Erectile Function
- ClinicalTrials.gov ID
- NCT02006927
- Acronym / sponsor ID
- 2013-420
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kenneth M Peters, MDUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- Jul 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve Stimulation | Experimental | Device: Nerve StimulationPlacement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve StimulationAlso: Lead stimulationPlacement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy | Device | Nerve Stimulation |
Primary outcome
Tolerability of Nerve Stimulation
Time frame: 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.
1 secondary outcome
Efficacy of Nerve Stimulation
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Peters, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Stimulation in people with Prostate Cancer, run by Kenneth M Peters, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Nerve Stimulation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.