Clinical Trials Logo

Clinical 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03425240
Study type Interventional
Source Laikon General District Hospital, Athens
Contact Spyridon Skoufias, MD
Phone spyskouf@hotmail.com
Email spyskouf@hotmail.com
Status Recruiting
Phase N/A
Start date September 10, 2014
Completion date December 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT02945813 - SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy Phase 2
Active, not recruiting NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Completed NCT02124668 - A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy Phase 2
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Active, not recruiting NCT00779168 - White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy Phase 1
Recruiting NCT02799706 - Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer Phase 3
Recruiting NCT01990196 - Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer Phase 2
Recruiting NCT03327675 - High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer N/A
Active, not recruiting NCT01420250 - Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer Phase 1
Active, not recruiting NCT02766543 - Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer Phase 2
Completed NCT01447186 - Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men N/A
Not yet recruiting NCT03495479 - Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Not yet recruiting NCT03419585 - The "PC-LIGHT" Study N/A