Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

NCT ID: NCT02974673

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2018-10-18

Brief Summary

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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

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Conditions

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Spinal Cord Diseases Disorder of Ejaculation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ejaculatory test

Measures of sphincter pressures during ejaculation

Group Type EXPERIMENTAL

Ejaculatory test

Intervention Type PROCEDURE

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

Interventions

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Ejaculatory test

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Gabriel Previnaire, MD

Role: STUDY_DIRECTOR

Centre Calvé - Berck sur mer

Jean Marc Soler, MD

Role: PRINCIPAL_INVESTIGATOR

Center Bouffard Vercelli - Cerbère

Locations

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Centre Calvé

Berck, , France

Site Status

Centre Bouffard Vercelli

Cervera de la Marenda, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01441-50

Identifier Type: OTHER

Identifier Source: secondary_id

RC-P0052

Identifier Type: -

Identifier Source: org_study_id

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