Status:
UNKNOWN
Intra-operative Neuromodulation of the Pelvic Plexus
Lead Sponsor:
Laikο General Hospital, Athens
Conditions:
Erectile Dysfunction
Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
NA
Brief 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 (prostatect...
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 no...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03425240
Start Date
September 10 2014
End Date
December 1 2018
Last Update
February 8 2018
Active Locations (1)
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1
Laikon General Hospital of Athens
Athens, Greece, 11527