Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Diseases, Disorder of Ejaculation

Intervention / Treatment
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* Procedure: Ejaculatory test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at inclusion | 
| 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 | at inclusion | 
| 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 | at inclusion | 
| Frequency of ejaculation after stimulation | The stimulation parameters will be measured during vibro massage | at inclusion | 
| Amplitude of ejaculation after stimulation | The stimulation parameters will be measured during vibro massage | at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Genito sexuals disorders, Ejaculatory test