Erectile DysfunctionNCT03425240
Intra-operative Neuromodulation of the Pelvic Plexus
A study testing Nerve Stimulation in people with Erectile Dysfunction and Prostate Cancer, run by Laikο General Hospital, Athens at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy). Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction, 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
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 10 Sep 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for open radical prostatectomy procedure under total anesthesia.
- Age 40 to 75 years old.
- Able to read and understand patient information materials and willing to sign a written informed consent.
Who cannot join
- Have been diagnosed with severe vasculogenic erectile dysfunction.
- Have a prior history of pelvic surgery, trauma or irradiation therapy.
- Have a penile prosthesis.
- Have been diagnosed with neurologic diseases that may negatively impact erectile functions.
- Currently having an active implantable device (such as a pacemaker).
- Posses any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study.
- Inability to provide a fully informed consent.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Laikon General Hospital of Athens
Athens, 11527
Spyridon Skoufias, MD, spyskouf@hotmail.com, spyskouf@hotmail.com
About this study
The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).
Read the detailed description
Prostate cancer is the main cancer in men. However, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (RP), the gold standard treatment for non-metastatic cancers. Unfortunately, despite providing optimal cancer control, RP often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not been able to prove a beneficial action yet. However, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. Therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy.
The primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. During standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded.
The secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.
- Conditions
- Erectile Dysfunction, Prostate Cancer
- Being tested
- Nerve Stimulation
- Keywords
- Erectile Dysfunction, Prostate Cancer, Neuromodulation
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve StimulationDevice
Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Stimulation | Experimental | Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy. Receives: Device: Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile circumference increase in millimeters.
Change in penile circumference [mm] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.
Measured: 5 minutes
Secondary outcomes (2)
Anatomic location of stimulation site
The anatomic location of the stimulation site on the pelvic floor (determined by the surgeon).
Measured: 5 to 15 minutes
Stimulation threshold in volts
Amplitude in volts of the electrical stimulation pulses to induce penile response.
Measured: 5 to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start10 Sep 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laikο General Hospital, Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ioannis Adamakis, Laikο General Hospital, Athens
- Investigators
- Ioannis Adamakis, MD, Principal investigator, Laikon General Hospital of AthensConstantinos A. Constantinides, MD, Study chair, Laikon General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425240
- Sponsor's protocol ID
- 7818
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Neuromodulation of the Pelvic Plexus
- ClinicalTrials.gov ID
- NCT03425240
- Acronym / sponsor ID
- 7818
- Conditions
- Erectile Dysfunction, Prostate Cancer
- Keywords
- Erectile Dysfunction, Prostate Cancer, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laikο General Hospital, AthensUniversity, hospital or other
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).
Detailed description
Prostate cancer is the main cancer in men. However, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (RP), the gold standard treatment for non-metastatic cancers. Unfortunately, despite providing optimal cancer control, RP often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not been able to prove a beneficial action yet. However, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. Therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy.
The primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. During standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded.
The secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve Stimulation | Experimental | Device: Nerve StimulationAcute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for open radical prostatectomy procedure under total anesthesia.
- Age 40 to 75 years old.
- Able to read and understand patient information materials and willing to sign a written informed consent.
Key exclusion criteria (7 listed)
- Have been diagnosed with severe vasculogenic erectile dysfunction.
- Have a prior history of pelvic surgery, trauma or irradiation therapy.
- Have a penile prosthesis.
- Have been diagnosed with neurologic diseases that may negatively impact erectile functions.
- Currently having an active implantable device (such as a pacemaker).
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 StimulationAcute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy. | Device | Nerve Stimulation |
Primary outcome
Penile circumference increase in millimeters.
Time frame: 5 minutes
Change in penile circumference [mm] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.
2 secondary outcomes
Anatomic location of stimulation site
Time frame: 5 to 15 minutes
Stimulation threshold in volts
Time frame: 5 to 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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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.
Ioannis Adamakis, MD principal investigator
Laikon General Hospital of Athens
Constantinos A. Constantinides, MD study chair
Laikon General Hospital of Athens
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 Erectile Dysfunction and Prostate Cancer, run by Laikο General Hospital, Athens at 1 site in Greece.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Feb 2018. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Spyridon Skoufias, MD (spyskouf@hotmail.com, spyskouf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penile circumference increase in millimeters. (time frame: 5 minutes). 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 8 Feb 2018.