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Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters (EDGE)

Primary Purpose

Spinal Cord Diseases, Disorder of Ejaculation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ejaculatory test
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Cord Diseases focused on measuring Spinal Cord Injury, Genito sexuals disorders, Ejaculatory test

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients evaluated by ejaculatory test during their usual care
  • Men with spinal cord injury between 18 and 65 years old
  • Patients who have given their informed consent
  • Patients with social insurance affiliation

Exclusion Criteria:

  • Minors
  • Patients with justice protection
  • Patients over 65 years old

Sites / Locations

  • Centre Calvé
  • Centre Bouffard Vercelli

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ejaculatory test

Arm Description

Measures of sphincter pressures during ejaculation

Outcomes

Primary Outcome Measures

Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia
The presence of an ejaculatory dyssynergia will be certify by analysis of sphincter urethral pressure curves registered by microsensors during ejaculation

Secondary Outcome Measures

Determination of type of ejaculation by bladder catheterization
The type of ejaculation ( antegrade, retrograde or mixed) will be determined by searching sperm in urines due to a bladder catheterization after ejaculation
Sphincter urethral pressure to asses type of ejaculatory dyssynergia
The type of ejaculatory dyssynergia will be determined by analysis of sphincter urethral pressures curves during ejaculation
American Spinal Injury Association score
The neurological examination will be done by measuring the American Spinal Injury Association score, the international standard for evaluation of spinal cord injury
Frequency of ejaculation after stimulation
The stimulation parameters will be measured during vibro massage
Amplitude of ejaculation after stimulation
The stimulation parameters will be measured during vibro massage

Full Information

First Posted
November 7, 2016
Last Updated
June 3, 2020
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT02974673
Brief Title
Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
Acronym
EDGE
Official Title
Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this research is to study the sphincter activity during ejaculation in patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this purpose, using a catheter the protocol plans to measure the sphincter pressures during ejaculation. Moreover, cardiovascular parameters will be measured continuously during the ejaculatory test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Diseases, Disorder of Ejaculation
Keywords
Spinal Cord Injury, Genito sexuals disorders, Ejaculatory test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ejaculatory test
Arm Type
Experimental
Arm Description
Measures of sphincter pressures during ejaculation
Intervention Type
Procedure
Intervention Name(s)
Ejaculatory test
Intervention Description
Measures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury.
Primary Outcome Measure Information:
Title
Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia
Description
The presence of an ejaculatory dyssynergia will be certify by analysis of sphincter urethral pressure curves registered by microsensors during ejaculation
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Determination of type of ejaculation by bladder catheterization
Description
The type of ejaculation ( antegrade, retrograde or mixed) will be determined by searching sperm in urines due to a bladder catheterization after ejaculation
Time Frame
at inclusion
Title
Sphincter urethral pressure to asses type of ejaculatory dyssynergia
Description
The type of ejaculatory dyssynergia will be determined by analysis of sphincter urethral pressures curves during ejaculation
Time Frame
at inclusion
Title
American Spinal Injury Association score
Description
The neurological examination will be done by measuring the American Spinal Injury Association score, the international standard for evaluation of spinal cord injury
Time Frame
at inclusion
Title
Frequency of ejaculation after stimulation
Description
The stimulation parameters will be measured during vibro massage
Time Frame
at inclusion
Title
Amplitude of ejaculation after stimulation
Description
The stimulation parameters will be measured during vibro massage
Time Frame
at inclusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients evaluated by ejaculatory test during their usual care Men with spinal cord injury between 18 and 65 years old Patients who have given their informed consent Patients with social insurance affiliation Exclusion Criteria: Minors Patients with justice protection Patients over 65 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Gabriel Previnaire, MD
Organizational Affiliation
Centre Calvé - Berck sur mer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean Marc Soler, MD
Organizational Affiliation
Center Bouffard Vercelli - Cerbère
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Calvé
City
Berck
ZIP/Postal Code
62608
Country
France
Facility Name
Centre Bouffard Vercelli
City
Cerbere
ZIP/Postal Code
66290
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

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