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

Primary Purpose

Premature Ejaculation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)
Total attention
Humour
Take the drama out
Question about premature ejaculation
Symptoms of premature ejaculation
Help to verbalize
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premature Ejaculation focused on measuring Premature ejaculation, general practice, sexual dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinet médical
  • Cabinet médical - 89 Bis Rue de la Calade
  • Cabinet médical
  • Cabinet médical
  • Cabinet médical - Esplanade Mitterrand 5
  • Cabinet de médecine générale
  • Cabinet du 122 rue Paul Masson
  • Cabinet médical Place J. London
  • Cabinet médical
  • Cabinet médical
  • Pôle universitaire de Lanmeur
  • Cabinet médical
  • Cabinet médical
  • Cabinet médical
  • Cabinet médical du 38 Bd 1848
  • Cabinet de médecine générale
  • Cabinet de médecine générale
  • Cabinet médical du 5 Descente des Oliviers
  • Cabinet médical
  • Groupe médical Tourren
  • Cabinet de médecine générale
  • Cabinet médical
  • Cabinet médical - 39 rue Saint Philibert

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Interventional GP : GP trainned in communication skills

Usual care : GP did not trainnd in communication skills

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 3, 2015
Last Updated
October 15, 2020
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02378779
Brief Title
Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
Acronym
GETUP
Official Title
Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Multiple reminders were carried out but despite these measures, the GP has not enough participated .
Study Start Date
April 22, 2016 (Actual)
Primary Completion Date
April 22, 2018 (Actual)
Study Completion Date
April 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Premature ejaculation, general practice, sexual dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 .
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional GP : GP trainned in communication skills
Arm Type
Other
Arm Description
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).
Arm Title
Usual care : GP did not trainnd in communication skills
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Total attention
Intervention Description
Total attention of the GP to approach the subject of premature ejaculation during all the consultation
Intervention Type
Other
Intervention Name(s)
Humour
Intervention Description
Use the humour to approach the subject of premature ejaculation
Intervention Type
Other
Intervention Name(s)
Take the drama out
Intervention Description
Take the drama out to approach the subject of premature ejaculation
Intervention Type
Other
Intervention Name(s)
Question about premature ejaculation
Intervention Description
Question about premature ejaculation during the GP consultation
Intervention Type
Other
Intervention Name(s)
Symptoms of premature ejaculation
Intervention Description
GP's observation about signs of premature ejaculation
Intervention Type
Other
Intervention Name(s)
Help to verbalize
Intervention Description
Help for the patient to speak about premature ejaculation
Primary Outcome Measure Information:
Title
The impact of training general practitioners in communication skills
Description
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.
Time Frame
Day 0 - 4 weeks
Secondary Outcome Measure Information:
Title
Evaluation of quality of life
Description
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.
Time Frame
Day 0 - 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie BARAIS, GP
Organizational Affiliation
GP department, ERCR SPURBO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet médical
City
Ambert
ZIP/Postal Code
63600
Country
France
Facility Name
Cabinet médical - 89 Bis Rue de la Calade
City
Assas
ZIP/Postal Code
34820
Country
France
Facility Name
Cabinet médical
City
Augerolles
ZIP/Postal Code
63930
Country
France
Facility Name
Cabinet médical
City
Avermes
ZIP/Postal Code
0300
Country
France
Facility Name
Cabinet médical - Esplanade Mitterrand 5
City
Bellerive-sur-Allier
ZIP/Postal Code
03700
Country
France
Facility Name
Cabinet de médecine générale
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Cabinet du 122 rue Paul Masson
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Cabinet médical Place J. London
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Cabinet médical
City
Clarensac
ZIP/Postal Code
30870
Country
France
Facility Name
Cabinet médical
City
Fleury
ZIP/Postal Code
11560
Country
France
Facility Name
Pôle universitaire de Lanmeur
City
Lanmeur
ZIP/Postal Code
29620
Country
France
Facility Name
Cabinet médical
City
Le Mayet de Montagne
ZIP/Postal Code
03250
Country
France
Facility Name
Cabinet médical
City
Le Puy En Velay
ZIP/Postal Code
43000
Country
France
Facility Name
Cabinet médical
City
Lempdes sur Allagnon
ZIP/Postal Code
43410
Country
France
Facility Name
Cabinet médical du 38 Bd 1848
City
Narbonne
ZIP/Postal Code
11000
Country
France
Facility Name
Cabinet de médecine générale
City
Ondres
ZIP/Postal Code
40440
Country
France
Facility Name
Cabinet de médecine générale
City
Pont de Buis Les Quimerch
Country
France
Facility Name
Cabinet médical du 5 Descente des Oliviers
City
Restinclières
ZIP/Postal Code
34160
Country
France
Facility Name
Cabinet médical
City
Saint Nicolas du Pelem
ZIP/Postal Code
22480
Country
France
Facility Name
Groupe médical Tourren
City
Saint Vincent de Tyrosse
ZIP/Postal Code
40230
Country
France
Facility Name
Cabinet de médecine générale
City
Saubrigues
ZIP/Postal Code
40230
Country
France
Facility Name
Cabinet médical
City
Thézan Les Béziers
ZIP/Postal Code
34490
Country
France
Facility Name
Cabinet médical - 39 rue Saint Philibert
City
Trégunc
ZIP/Postal Code
29910
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30419940
Citation
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.
Results Reference
derived

Learn more about this trial

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

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