NCT02284659

Brief Summary

Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction. Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Status
completed

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

First Submitted

Initial submission to the registry

October 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

October 31, 2014

Last Update Submit

March 5, 2015

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Erectile function with International Index of Erectile Function-5 questionnaire

    2 times a week for 30 minutes

Study Arms (2)

FES-sham

SHAM COMPARATOR

Functional Electro Stimulation (FES-sham)

Device: FES- Sham

Intervention (FES)

ACTIVE COMPARATOR

functional electro stimulation

Device: Functional Electrical Stimulation (FES)

Interventions

Functional Electrical Stimulation (FES)DEVICE

FES (50Hz / 500us)

Intervention (FES)
FES- ShamDEVICE
FES-sham

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patient
  • to 65 years of age, with stable marital relationship (6 months)
  • Diagnosis of erectile dysfunction (score of less than 22 IIEF5)
  • Clinical history of ED for at least 6 months

You may not qualify if:

  • A neurogenic (spinal cord injury, Parkinson's, MS, post prostatectomy)
  • Hypogonadism (total testosterone \<300 ng / dl)
  • Patient reporting use of inhibitors or 5PDE FIC in the last 60 days
  • Diagnosis of coronary artery disease and / or cerebrovascular disease
  • Impossibility of understanding the goals, technical study and informed consent cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 6, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03