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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02974673
Recruitment Status : Terminated (lack of recruitment)
First Posted : November 28, 2016
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Diseases Disorder of Ejaculation Procedure: Ejaculatory test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : October 18, 2018


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Frequency of ejaculation after stimulation [ Time Frame: at inclusion ]
    The stimulation parameters will be measured during vibro massage

  5. Amplitude of ejaculation after stimulation [ Time Frame: at inclusion ]
    The stimulation parameters will be measured during vibro massage



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974673


Locations
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France
Centre Calvé
Berck, France, 62608
Centre Bouffard Vercelli
Cerbere, France, 66290
Sponsors and Collaborators
Lille Catholic University
Investigators
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Study Director: Jean Gabriel Previnaire, MD Centre Calvé - Berck sur mer
Principal Investigator: Jean Marc Soler, MD Center Bouffard Vercelli - Cerbère
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02974673    
Other Study ID Numbers: RC-P0052
2016-A01441-50 ( Other Identifier: ANSM )
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
Spinal Cord Injury
Genito sexuals disorders
Ejaculatory test
Additional relevant MeSH terms:
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Spinal Cord Diseases
Ataxia
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms