NCT03425240

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 (prostatectomy).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

4.2 years

First QC Date

January 24, 2018

Last Update Submit

February 7, 2018

Conditions

Erectile DysfunctionProstate Cancer

Keywords

Erectile DysfunctionProstate CancerNeuromodulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 minutes

Secondary Outcomes (2)

  • Anatomic location of stimulation site

    5 to 15 minutes

  • Stimulation threshold in volts

    5 to 15 minutes

Study Arms (1)

Nerve Stimulation

EXPERIMENTAL

Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.

Device: Nerve Stimulation

Interventions

Nerve StimulationDEVICE

Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.

Nerve Stimulation

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laikon General Hospital of Athens

Athens, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Erectile DysfunctionProstatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsProstatic Diseases

Study Officials

  • Ioannis Adamakis, MD

    Laikon General Hospital of Athens

    PRINCIPAL INVESTIGATOR

  • Constantinos A. Constantinides, MD

    Laikon General Hospital of Athens

    STUDY CHAIR

Central Study Contacts

Spyridon Skoufias, MD

CONTACT

spyskouf@hotmail.comspyskouf@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal investigator

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 7, 2018

Study Start

September 10, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

GR(1)