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Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02974673
Acronym
EDGE
Enrollment
11
Registered
2016-11-28
Start date
2017-02-15
Completion date
2018-10-18
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Ejaculation, Spinal Cord Diseases

Keywords

Spinal Cord Injury, Genito sexuals disorders, Ejaculatory test

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.

Interventions

PROCEDUREEjaculatory test

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

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergiaat inclusionThe presence of an ejaculatory dyssynergia will be certify by analysis of sphincter urethral pressure curves registered by microsensors during ejaculation

Secondary

MeasureTime frameDescription
Determination of type of ejaculation by bladder catheterizationat inclusionThe 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 dyssynergiaat inclusionThe type of ejaculatory dyssynergia will be determined by analysis of sphincter urethral pressures curves during ejaculation
American Spinal Injury Association scoreat inclusionThe 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 stimulationat inclusionThe stimulation parameters will be measured during vibro massage
Amplitude of ejaculation after stimulationat inclusionThe stimulation parameters will be measured during vibro massage

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026