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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378779
Recruitment Status : Terminated (Multiple reminders were carried out but despite these measures, the GP has not enough participated .)
First Posted : March 4, 2015
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: The study is based on the participation of general practitioners in a training, the test is necessarily open for doctors. However patients will not know if their doctor has received training and will be blinded .
Primary Purpose: Diagnostic
Official Title: Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
Actual Study Start Date : April 22, 2016
Actual Primary Completion Date : April 22, 2018
Actual Study Completion Date : April 22, 2018
Arms and Interventions
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Arm Intervention/treatment
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
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378779


Locations
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Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Marie BARAIS, GP GP department, ERCR SPURBO
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02378779    
Other Study ID Numbers: GETUP
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After result publication
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
Keywords provided by University Hospital, Brest:
Premature ejaculation
general practice
sexual dysfunction
Additional relevant MeSH terms:
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Premature Ejaculation
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders