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

Primary Purpose

Erectile Dysfunction, Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sexology consultation
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Gabriel MartinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sexology consultation

Leaflet concerning erectile disorders

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Measurement of HbA1c according to the randomisation group

Secondary Outcome Measures

Full Information

First Posted
September 9, 2016
Last Updated
September 14, 2016
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT02899572
Brief Title
Impact of a Sexology Consultation on Disease Control of Type 2 Male Diabetics With Erectile Dysfunction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sexology consultation
Arm Type
Experimental
Arm Description
specialized sexology consultation planned in the 15 days after inclusion. Randomisation is performed at D7 during a phone call to the patient.
Arm Title
Leaflet concerning erectile disorders
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sexology consultation
Intervention Description
a sexology consultation is planned in the 15 days after inclusion
Primary Outcome Measure Information:
Title
Measurement of HbA1c according to the randomisation group
Time Frame
3 months after inclusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie DUTET, PharmD, PhD
Phone
+33262905282
Email
julie.dutet@chu-reunion.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Céline REGNIER, MD
Email
regnier.c@ch-gmartin.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline REGNIER, MD
Organizational Affiliation
CH Gabriel Martin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Gabriel Martin
City
Saint Paul
ZIP/Postal Code
97460
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline REGNIER, MD
Email
regnier.c@ch-gmartin.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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