Premature EjaculationGETUPNCT02378779
Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
A study testing Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool), Total attention and Humour in people with Premature Ejaculation, run by University Hospital, Brest at 23 sites in France.
Trial summary
Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59 have admitted suffering from a decrease in, or loss of control of, their ejaculation. The quality of life of patients and their partners is impaired compared to men not suffering from premature ejaculation. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool), Total attention and Humour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 23 sitesFrance
- Study dates
- 22 Apr 2016to 22 Apr 2018
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients overbetween 18 and 80 years old and
- Patients consulting for a sexual, urogenital or psychological reason according to Interntational Classification of Primary Care (ICPC-2) will be included.
Who cannot join
- Patients consulting for Aanother reason for visiting thethan urogenital pattern, sexual or psychological
- Nonunderstanding of the French language
- Patients with psychiatric disorders affecting judgement
- Patient refusal to participate in the study
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Cabinet médical
Ambert, 63600
Cabinet médical - 89 Bis Rue de la Calade
Assas, 34820
Cabinet médical
Augerolles, 63930
Cabinet médical
Avermes, 0300
Cabinet médical - Esplanade Mitterrand 5
Bellerive-sur-Allier, 03700
Cabinet de médecine générale
Brest, 29200
Cabinet du 122 rue Paul Masson
Brest, 29200
Cabinet médical Place J. London
Brest, 29200
Cabinet médical
Clarensac, 30870
Cabinet médical
Fleury, 11560
Pôle universitaire de Lanmeur
Lanmeur, 29620
Cabinet médical
Le Mayet-de-Montagne, 03250
Cabinet médical
Le Puy-en-Velay, 43000
Cabinet médical
Lempdes-sur-Allagnon, 43410
Cabinet médical du 38 Bd 1848
Narbonne, 11000
Cabinet de médecine générale
Ondres, 40440
Cabinet de médecine générale
Pont-de-Buis-lès-Quimerch
Cabinet médical du 5 Descente des Oliviers
Restinclières, 34160
Cabinet médical
Saint-Nicolas-du-Pélem, 22480
Groupe médical Tourren
Saint-Vincent-de-Tyrosse, 40230
Cabinet de médecine générale
Saubrigues, 40230
Cabinet médical
Thézan Les Béziers, 34490
Cabinet médical - 39 rue Saint Philibert
Trégunc, 29910
About this study
Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59 have admitted suffering from a decrease in, or loss of control of, their ejaculation. The quality of life of patients and their partners is impaired compared to men not suffering from premature ejaculation. Economically, the impact of the disease are significant. In the year preceding the detection of premature ejaculation patients visit twice their physician. The majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting room, considered it important to talk with their GP about their sexual concerns. Almost half of them preferred that their GP initiate any discussions about sexuality. More than two thirds of the respondents would have liked their GP to signal his or her open-mindedness by directly addressing sexual topics during the consultation. In 2008 a qualitative study brought to the fore the strategies used by GPs to initiate the discussion on premature ejaculation . GPs who mentioned premature ejaculation with their patient described three attitude-related strategies and three investigative strategies.
- Conditions
- Premature Ejaculation
- Being tested
- Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool), Total attention, Humour, Take the drama out, Question about premature ejaculation
- Keywords
- Premature ejaculation, general practice, sexual dysfunction
- Medical subject headings
- Premature Ejaculation, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)Other
The SF-12 was designed to measure general health status from the patient's point of view (12 questions are asking to the patients) and the PEDT questionnaire is a self-assessment questionnaire to diagnose premature ejaculation (5 questions are asking to the patients).
Total attentionOther
Total attention of the GP to approach the subject of premature ejaculation during all the consultation
HumourOther
Use the humour to approach the subject of premature ejaculation
Take the drama outOther
Take the drama out to approach the subject of premature ejaculation
Question about premature ejaculationOther
Question about premature ejaculation during the GP consultation
Symptoms of premature ejaculationOther
GP's observation about signs of premature ejaculation
Help to verbalizeOther
Help for the patient to speak about premature ejaculation
| Study group | Role | What they receive |
|---|---|---|
| Interventional GP : GP trainned in communication skills | Other | The subjects have to answer to the questionary SF12 on pre and post consultation to evaluate the quality of life.
He must so answer to the questionary PEDT. Then the interventional GP group must use one of the six strategies to approach the subject of premature ejaculation.
There three strategies of attitude (Total attention, Humour, Take the drama out) and three investigative strategies (Question about premature ejaculation, Symptoms of premature ejaculation, Help to verbalize). Receives: Other: Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool); Other: Total attention; Other: Humour; Other: Take the drama out; Other: Question about premature ejaculation; Other: Symptoms of premature ejaculation; Other: Help to verbalize |
| Usual care : GP did not trainnd in communication skills | Other | The subjects have to answer to the questionary SF12 on pre and post consultation to evaluate the quality of life.
He must so answer to the questionary PEDT. This classical GP group make a classical consultation like each day without use any strategies to speak about Receives: Other: Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of training general practitioners in communication skills
The impact of training general practitioners in communication skills on the rate of patients bringing up the topic of premature ejaculation with their GP. To measure the proportions of patients bringing up the topic of premature ejaculation with their GP, the GPs in the two groups were asked to fill in a questionnaire after the consultation on whether the topics tackled were genital, urinary or psychological. The aim of detailing the different topics broached was to avoid contamination bias in the control group.
Measured: Day 0 - 4 weeks
Secondary outcomes (1)
Evaluation of quality of life
The quality of life will be evaluated with the SF-12 health assessment scale. The SF-12 was designed to measure general health status from the patient's point of view. The SF-12 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health.
Measured: Day 0 - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start22 Apr 2016
- Primary completion22 Apr 2018
- Study completion22 Apr 2018
Why it stopped: Multiple reminders were carried out but despite these measures, the GP has not enough participated .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter trial. Patients will be followed either by GPs from the interventional group who trained in communication skills or by the control group who never participated. The distribution of general practitioners in the groups is done thanks random draw .
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie BARAIS, GP, Principal investigator, GP department, ERCR SPURBO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378779
- Sponsor's protocol ID
- GETUP
- Acronym
- GETUP
- Status last verified
- Oct 2020
- First submitted
- 3 Feb 2015
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Barais M, Vaillant Roussel H, Costa D, Derriennic J, Pereira B, Cadier S. Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason - GET UP: study protocol for a cluster randomised controlled trial. Trials. 2018 Nov 12;19(1):622. doi: 10.1186/s13063-018-2947-2.
PubMed 30419940
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
- ClinicalTrials.gov ID
- NCT02378779
- Acronym / sponsor ID
- GETUP / GETUP
- Conditions
- Premature Ejaculation
- Keywords
- Premature ejaculation, general practice, sexual dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Multiple reminders were carried out but despite these measures, the GP has not enough participated .
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 22 Apr 2018 (actual)
- Study completion
- 22 Apr 2018 (actual)
- First posted
- 4 Mar 2015 (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.
Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59 have admitted suffering from a decrease in, or loss of control of, their ejaculation. The quality of life of patients and their partners is impaired compared to men not suffering from premature ejaculation. Economically, the impact of the disease are significant. In the year preceding the detection of premature ejaculation patients visit twice their physician. The majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting room, considered it important to talk with their GP about their sexual concerns. Almost half of them preferred that their GP initiate any discussions about sexuality. More than two thirds of the respondents would have liked their GP to signal his or her open-mindedness by directly addressing sexual topics during the consultation. In 2008 a qualitative study brought to the fore the strategies used by GPs to initiate the discussion on premature ejaculation . GPs who mentioned premature ejaculation with their patient described three attitude-related strategies and three investigative strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a multicenter trial. Patients will be followed either by GPs from the interventional group who trained in communication skills or by the control group who never participated. The distribution of general practitioners in the groups is done thanks random draw .
| Arm | Type | Receives |
|---|---|---|
| Interventional GP : GP trainned in communication skills | Other | Other: Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool), Other: Total attention, Other: Humour, Other: Take the drama out, Other: Question about premature ejaculation, Other: Symptoms of premature ejaculation, Other: Help to verbalizeThe subjects have to answer to the questionary SF12 on pre and post consultation to evaluate the quality of life. He must so answer to the questionary PEDT. Then the interventional GP group must use one of the six strategies to approach the subject of premature ejaculation. There three strategies of attitude (Total attention, Humour, Take the drama out) and three investigative strategies (Question about premature ejaculation, Symptoms of premature ejaculation, Help to verbalize). |
| Usual care : GP did not trainnd in communication skills | Other | Other: Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)The subjects have to answer to the questionary SF12 on pre and post consultation to evaluate the quality of life. He must so answer to the questionary PEDT. This classical GP group make a classical consultation like each day without use any strategies to speak about |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male patients overbetween 18 and 80 years old and
- Patients consulting for a sexual, urogenital or psychological reason according to Interntational Classification of Primary Care (ICPC-2) will be included.
Key exclusion criteria (4 listed)
- Patients consulting for Aanother reason for visiting thethan urogenital pattern, sexual or psychological
- Nonunderstanding of the French language
- Patients with psychiatric disorders affecting judgement
- Patient refusal to participate in the study
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 |
|---|---|---|
| Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)The SF-12 was designed to measure general health status from the patient's point of view (12 questions are asking to the patients) and the PEDT questionnaire is a self-assessment questionnaire to diagnose premature ejaculation (5 questions are asking to the patients). | Other | Interventional GP : GP trainned in communication skills, Usual care : GP did not trainnd in communication skills |
| Total attentionTotal attention of the GP to approach the subject of premature ejaculation during all the consultation | Other | Interventional GP : GP trainned in communication skills |
| HumourUse the humour to approach the subject of premature ejaculation | Other | Interventional GP : GP trainned in communication skills |
| Take the drama outTake the drama out to approach the subject of premature ejaculation | Other | Interventional GP : GP trainned in communication skills |
| Question about premature ejaculationQuestion about premature ejaculation during the GP consultation | Other | Interventional GP : GP trainned in communication skills |
| Symptoms of premature ejaculationGP's observation about signs of premature ejaculation | Other | Interventional GP : GP trainned in communication skills |
| Help to verbalizeHelp for the patient to speak about premature ejaculation | Other | Interventional GP : GP trainned in communication skills |
Primary outcome
The impact of training general practitioners in communication skills
Time frame: Day 0 - 4 weeks
The impact of training general practitioners in communication skills on the rate of patients bringing up the topic of premature ejaculation with their GP. To measure the proportions of patients bringing up the topic of premature ejaculation with their GP, the GPs in the two groups were asked to fill in a questionnaire after the consultation on whether the topics tackled were genital, urinary or psychological. The aim of detailing the different topics broached was to avoid contamination bias in the control group.
1 secondary outcome
Evaluation of quality of life
Time frame: Day 0 - 4 weeks
Results and safety
The study was stopped early (reason given: Multiple reminders were carried out but despite these measures, the GP has not enough participated .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 30419940Barais M, Vaillant Roussel H, Costa D, Derriennic J, Pereira B, Cadier S. Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason - GET UP: study protocol for a cluster randomised controlled trial. Trials. 2018 Nov 12;19(1):622. doi: 10.1186/s13063-018-2947-2.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Marie BARAIS, GP principal investigator
GP department, ERCR SPURBO
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool), Total attention and Humour in people with Premature Ejaculation, run by University Hospital, Brest at 23 sites 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
The study was stopped early (reason given: Multiple reminders were carried out but despite these measures, the GP has not enough participated .). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of training general practitioners in communication skills (time frame: Day 0 - 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02378779, which also lists 1 linked publication.
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 19 Oct 2020.