Impact of a Sexology Consultation on Disease Control of Type 2 Male Diabetics With Erectile Dysfunction

NCT ID: NCT02899572

Last Updated: 2016-09-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-31

Brief Summary

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Erection disorders constitute the first sign of vascular injury in type 2 diabetes patients. The important frequency of these disorders and their consequences in term of quality of life have a strong contrast with the actual interest showed for them by the medical community.

Natural evolution of the disease and its management make that these disorders often occur little time after a therapeutic change. As a consequence, patients often accuse their medication to be responsible for the appearance of these disorders. This confusion, associated to false believes that may have the patients on their disease or their treatment, often leads to treatment discontinuation which has a deleterious effect on the disease evolution.

Educational therapy programs showed a positive impact on therapeutic adherence. Increasing patients' knowledge on their disease and treatments increases their therapeutic adherence and makes it easier to balance diabetes and therefore limits complications appearance.

Educational therapy programs concern today the disease, its process, its evolution, its treatments, their efficacy, their adverse effects but erection disorders are not specifically addressed.

This study aims to evaluate the impact of a sexology consultation on diabetes balance measured via HbA1c rate. This consultation aims at precising this particular symptom of erection disorders, without any medicine prescription. The aim is to explain to patients the different links between their symptoms, diabetes, medicines and themselves.

Detailed Description

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Conditions

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Erectile Dysfunction Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sexology consultation

specialized sexology consultation planned in the 15 days after inclusion. Randomisation is performed at D7 during a phone call to the patient.

Group Type EXPERIMENTAL

Sexology consultation

Intervention Type PROCEDURE

a sexology consultation is planned in the 15 days after inclusion

Leaflet concerning erectile disorders

leaflet explaining erectile disorders related to type 2 diabetes will be sent by post to the patients. Randomisation is performed at D7 during a phone call to the patient.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sexology consultation

a sexology consultation is planned in the 15 days after inclusion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetic male medically treated
* aged from 18 to 65 years old included
* having issue obtaining or maintaining an erection allowing a satisfying sexual intercourse
* hospitalised or followed in consultation in one of the 2 participating sites

Exclusion Criteria

* treated by a medicine which could be responsible for the erectile disorders (beta-blockers, central anti-hypertensive drugs, antialdosterones)
* presenting another disease which could be responsible for the erectile disorders (neurological, hormonal, vascular, psychiatric diseases)
* treated by an insulin pump
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline REGNIER, MD

Role: PRINCIPAL_INVESTIGATOR

CH Gabriel Martin

Locations

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Centre Hospitalier Gabriel Martin

Saint-Paul, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julie DUTET, PharmD, PhD

Role: CONTACT

+33262905282

Céline REGNIER, MD

Role: CONTACT

Facility Contacts

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Céline REGNIER, MD

Role: primary

Other Identifiers

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2015/CHU/01

Identifier Type: -

Identifier Source: org_study_id

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