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

June 3, 2020 updated by: Lille Catholic University

Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Berck, France, 62608
        • Centre Calvé
      • Cerbere, France, 66290
        • Centre Bouffard Vercelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ejaculatory test
Measures of sphincter pressures during ejaculation
Procedure: Ejaculatory test
Measures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia
Time Frame: at inclusion
The presence of an ejaculatory dyssynergia will be certify by analysis of sphincter urethral pressure curves registered by microsensors during ejaculation
at inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Study Director: Jean Gabriel Previnaire, MD, Centre Calvé - Berck sur mer
  • Principal Investigator: Jean Marc Soler, MD, Center Bouffard Vercelli - Cerbère

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

October 18, 2018

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0052
  • 2016-A01441-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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