Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

Not Applicable

Terminated

• Conditions: Spinal Cord Diseases; Disorder of Ejaculation
• Interventions: Procedure: Ejaculatory test

• Registration Number: NCT02974673
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Study Start: 2017-02-15
• Primary Completion: 2018-10-18
• Study Completion: 2018-10-18
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ejaculatory test	Ejaculatory test	Measures of sphincter pressures during ejaculation

Primary Outcome Measures

Name	Time	Method
Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia	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

Name	Time	Method
Determination of type of ejaculation by bladder catheterization	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
Sphincter urethral pressure to asses type of ejaculatory dyssynergia	at inclusion	The type of ejaculatory dyssynergia will be determined by analysis of sphincter urethral pressures curves during ejaculation
American Spinal Injury Association score	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
Frequency of ejaculation after stimulation	at inclusion	The stimulation parameters will be measured during vibro massage
Amplitude of ejaculation after stimulation	at inclusion	The stimulation parameters will be measured during vibro massage

Trial Locations

Locations (2)

Centre Bouffard Vercelli; 🇫🇷 Cerbere, France

Centre Calvé; 🇫🇷 Berck, France