Consultations Reason for Genital, Urinary or Psychological Humans in General Practice (GETUP)

October 15, 2020 updated by: University Hospital, Brest
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • France
      • Ambert, France, 63600
        • Cabinet Médical
      • Assas, France, 34820
        • Cabinet médical - 89 Bis Rue de la Calade
      • Augerolles, France, 63930
        • Cabinet Médical
      • Avermes, France, 0300
        • Cabinet Médical
      • Bellerive-sur-Allier, France, 03700
        • Cabinet médical - Esplanade Mitterrand 5
      • Brest, France, 29200
        • Cabinet de médecine générale
      • Brest, France, 29200
        • Cabinet du 122 rue Paul Masson
      • Brest, France, 29200
        • Cabinet médical Place J. London
      • Clarensac, France, 30870
        • Cabinet Médical
      • Fleury, France, 11560
        • Cabinet Médical
      • Lanmeur, France, 29620
        • Pôle universitaire de Lanmeur
      • Le Mayet de Montagne, France, 03250
        • Cabinet Médical
      • Le Puy En Velay, France, 43000
        • Cabinet Médical
      • Lempdes sur Allagnon, France, 43410
        • Cabinet Médical
      • Narbonne, France, 11000
        • Cabinet médical du 38 Bd 1848
      • Ondres, France, 40440
        • Cabinet de médecine générale
      • Pont de Buis Les Quimerch, France
        • Cabinet de médecine générale
      • Restinclières, France, 34160
        • Cabinet médical du 5 Descente des Oliviers
      • Saint Nicolas du Pelem, France, 22480
        • Cabinet Médical
      • Saint Vincent de Tyrosse, France, 40230
        • Groupe médical Tourren
      • Saubrigues, France, 40230
        • Cabinet de médecine générale
      • Thézan Les Béziers, France, 34490
        • Cabinet Médical
      • Trégunc, France, 29910
        • Cabinet médical - 39 rue Saint Philibert

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Interventional GP : GP trainned in communication skills

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).
Other: 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: Total attention
Total attention of the GP to approach the subject of premature ejaculation during all the consultation
Other: Humour
Use the humour to approach the subject of premature ejaculation
Other: Take the drama out
Take the drama out to approach the subject of premature ejaculation
Other: Question about premature ejaculation
Question about premature ejaculation during the GP consultation
Other: Symptoms of premature ejaculation
GP's observation about signs of premature ejaculation
Other: Help to verbalize
Help for the patient to speak about premature ejaculation
Other: Usual care : GP did not trainnd in communication skills

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
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 0 - 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of quality of life
Time Frame: Day 0 - 4 weeks
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.
Day 0 - 4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie BARAIS, GP, GP department, ERCR SPURBO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GETUP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

After result publication

IPD Sharing Access Criteria

The data that will support the findings of this study will be available when the findings will be published in a peerreview journal, from the corresponding author, upon reasonable request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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