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

September 14, 2016 updated by: Centre Hospitalier Universitaire de la Réunion

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sexology consultation
specialized sexology consultation planned in the 15 days after inclusion. Randomisation is performed at D7 during a phone call to the patient.
Procedure: Sexology consultation
a sexology consultation is planned in the 15 days after inclusion
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of HbA1c according to the randomisation group
Time Frame: 3 months after inclusion
3 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Céline REGNIER, MD, CH Gabriel Martin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/CHU/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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