Erectile DysfunctionRADOTESNCT02899572
Impact of a Sexology Consultation on Disease Control of Type 2 Male Diabetics With Erectile Dysfunction
A study testing Sexology consultation in people with Erectile Dysfunction and Type 2 Diabetes, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction, Type 2 Diabetes
- What is being tested?
- Sexology consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Céline REGNIER, MD contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Gabriel Martin
Saint-Paul, 97460
Céline REGNIER, MD, regnier.c@ch-gmartin.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Erectile Dysfunction, Type 2 Diabetes
- Being tested
- Sexology consultation
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexology consultationProcedure or surgery
a sexology consultation is planned in the 15 days after inclusion
| Study group | Role | What they receive |
|---|---|---|
| Sexology consultation | Experimental | specialized sexology consultation planned in the 15 days after inclusion. Randomisation is performed at D7 during a phone call to the patient. Receives: Procedure: Sexology consultation |
| Leaflet concerning erectile disorders | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Measurement of HbA1c according to the randomisation group
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline REGNIER, MD, Principal investigator, CH Gabriel Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899572
- Sponsor's protocol ID
- 2015/CHU/01
- Acronym
- RADOTES
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Sexology Consultation on Diabetes Disease Control of Type 2 Male Diabetics With Erectile Dysfunction: a Monocentric Randomised Comparative Study
- ClinicalTrials.gov ID
- NCT02899572
- Acronym / sponsor ID
- RADOTES / 2015/CHU/01
- Conditions
- Erectile Dysfunction, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexology consultation | Experimental | Procedure: Sexology consultationspecialized sexology consultation planned in the 15 days after inclusion. Randomisation is performed at D7 during a phone call to the patient. |
| Leaflet concerning erectile disorders | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexology consultationa sexology consultation is planned in the 15 days after inclusion | Procedure or surgery | Sexology consultation |
Primary outcome
Measurement of HbA1c according to the randomisation group
Time frame: 3 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline REGNIER, MD contact
Céline REGNIER, MD principal investigator
CH Gabriel Martin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexology consultation in people with Erectile Dysfunction and Type 2 Diabetes, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie DUTET, PharmD, PhD (+33262905282, julie.dutet@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of HbA1c according to the randomisation group (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.