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

Type 2 Diabetes Clinical Trial

— RADOTES  

Official title:

Impact of a Sexology Consultation on Diabetes Disease Control of Type 2 Male Diabetics With Erectile Dysfunction: a Monocentric Randomised Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02899572
• Other study ID #: 2015/CHU/01
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2016
• Last updated: September 14, 2016
• Start date: June 2015
• Est. completion date: January 2017

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Julie DUTET, PharmD, PhD
• Phone: +33262905282
• Email: julie.dutet[@]chu-reunion.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Type 2 Diabetes

Intervention

Procedure:
• Sexology consultation
a sexology consultation is planned in the 15 days after inclusion

Locations

Country	Name	City	State
France	Centre Hospitalier Gabriel Martin	Saint Paul

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of HbA1c according to the randomisation group		3 months after inclusion	No