Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

Spinal Cord Diseases Clinical Trial

— EDGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02974673
• Other study ID #: RC-P0052
• Secondary ID: 2016-A01441-50
• Status: Terminated
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: October 18, 2018

Study information

• Verified date: June 2020
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 18, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Disorder of Ejaculation
• Spinal Cord Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Centre Calvé	Berck
France	Centre Bouffard Vercelli	Cerbere

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Frequency of ejaculation after stimulation	The stimulation parameters will be measured during vibro massage	at inclusion
Secondary	Amplitude of ejaculation after stimulation	The stimulation parameters will be measured during vibro massage	at inclusion