Clinical trial NCT02899572: Impact of a Sexology Consultation on Disease Control of Type 2 Male Diabetics With Erectile Dysfunction
Official title: Impact of a Sexology Consultation on Diabetes Disease Control of Type 2 Male Diabetics With Erectile Dysfunction: a Monocentric Randomised Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Type 2 Diabetes
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of HbA1c according to the randomisation group
timeFrame: 3 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: France
facility: Centre Hospitalier Gabriel Martin
Study officials:
affiliation: CH Gabriel Martin
name: Céline REGNIER, MD
role: PRINCIPAL_INVESTIGATOR
References: