Spinal Cord DiseasesEDGENCT02974673
Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
A study testing Ejaculatory test in people with Spinal Cord Diseases and Disorder of Ejaculation, run by Lille Catholic University at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Spinal Cord Diseases, Disorder of Ejaculation
- What is being tested?
- Ejaculatory test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Feb 2017to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minors
- Patients with justice protection
- Patients over 65 years old
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Calvé
Berck, 62608
Centre Bouffard Vercelli
Cervera de la Marenda, 66290
About this study
Official title: Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
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
- Being tested
- Ejaculatory test
- Keywords
- Spinal Cord Injury, Genito sexuals disorders, Ejaculatory test
- Medical subject headings
- Spinal Cord Diseases, Ejaculatory Dysfunction, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ejaculatory testProcedure or surgery
Measures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| Ejaculatory test | Experimental | Measures of sphincter pressures during ejaculation Receives: Procedure: Ejaculatory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: at inclusion
Frequency of ejaculation after stimulation
The stimulation parameters will be measured during vibro massage
Measured: at inclusion
Amplitude of ejaculation after stimulation
The stimulation parameters will be measured during vibro massage
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start15 Feb 2017
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Gabriel Previnaire, MD, Study director, Centre Calvé - Berck sur merJean Marc Soler, MD, Principal investigator, Center Bouffard Vercelli - Cerbère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974673
- Sponsor's protocol ID
- RC-P0052
- Other IDs
- 2016-A01441-50
- Acronym
- EDGE
- Status last verified
- Jun 2020
- First submitted
- 7 Nov 2016
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
- ClinicalTrials.gov ID
- NCT02974673
- Acronym / sponsor ID
- EDGE / RC-P0052
- Conditions
- Spinal Cord Diseases, Disorder of Ejaculation
- Keywords
- Spinal Cord Injury, Genito sexuals disorders, Ejaculatory test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ejaculatory test | Experimental | Procedure: Ejaculatory testMeasures of sphincter pressures during ejaculation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Minors
- Patients with justice protection
- Patients over 65 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ejaculatory testMeasures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury. | Procedure or surgery | Ejaculatory test |
Primary outcome
Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia
Time frame: at inclusion
The presence of an ejaculatory dyssynergia will be certify by analysis of sphincter urethral pressure curves registered by microsensors during ejaculation
5 secondary outcomes
Determination of type of ejaculation by bladder catheterization
Time frame: at inclusion
Sphincter urethral pressure to asses type of ejaculatory dyssynergia
Time frame: at inclusion
American Spinal Injury Association score
Time frame: at inclusion
Frequency of ejaculation after stimulation
Time frame: at inclusion
Amplitude of ejaculation after stimulation
Time frame: at inclusion
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Gabriel Previnaire, MD study director
Centre Calvé - Berck sur mer
Jean Marc Soler, MD principal investigator
Center Bouffard Vercelli - Cerbère
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ejaculatory test in people with Spinal Cord Diseases and Disorder of Ejaculation, run by Lille Catholic University at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.