Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

NCT02974673 | Terminated

• 2 other identifiers: RC-P00522016-A01441-50
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Diseases; Disorder of Ejaculation

Keywords

Spinal Cord Injury; Genito sexuals disorders; Ejaculatory test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Determination of type of ejaculation by bladder catheterization

  at inclusion

• Sphincter urethral pressure to asses type of ejaculatory dyssynergia

  at inclusion

• American Spinal Injury Association score

  at inclusion

• Frequency of ejaculation after stimulation

  at inclusion

• Amplitude of ejaculation after stimulation

  at inclusion

Study Arms (1)

Ejaculatory test

EXPERIMENTAL

Measures of sphincter pressures during ejaculation

Procedure: Ejaculatory test

Interventions

Ejaculatory test PROCEDURE

Measures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury.

Ejaculatory test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minors
• Patients with justice protection
• Patients over 65 years old

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (2)

Centre Calvé

Berck, 62608, France

Location

Centre Bouffard Vercelli

Cervera de la Marenda, 66290, France

Location

MeSH Terms

Conditions

Spinal Cord Diseases; Ejaculatory Dysfunction; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jean Gabriel Previnaire, MD

  Centre Calvé - Berck sur mer

  STUDY DIRECTOR

• Jean Marc Soler, MD

  Center Bouffard Vercelli - Cerbère

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 28, 2016
• Study Start: February 15, 2017
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)