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

Sponsor

University Hospital, Brest (Other)

Overall Status

Terminated

CT.gov ID

NCT02378779

Collaborator

(none)

132

Enrollment

Locations

Arms

Actual Duration (Months)

5.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

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 .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 :

Apr 22, 2016

Actual Primary Completion Date :

Apr 22, 2018

Actual Study Completion Date :

Apr 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

The impact of training general practitioners in communication skills [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

Evaluation of quality of life [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cabinet médical	Ambert	France	63600
2	Cabinet médical - 89 Bis Rue de la Calade	Assas	France	34820
3	Cabinet médical	Augerolles	France	63930
4	Cabinet médical	Avermes	France	0300
5	Cabinet médical - Esplanade Mitterrand 5	Bellerive-sur-Allier	France	03700
6	Cabinet de médecine générale	Brest	France	29200
7	Cabinet du 122 rue Paul Masson	Brest	France	29200
8	Cabinet médical Place J. London	Brest	France	29200
9	Cabinet médical	Clarensac	France	30870
10	Cabinet médical	Fleury	France	11560
11	Pôle universitaire de Lanmeur	Lanmeur	France	29620
12	Cabinet médical	Le Mayet de Montagne	France	03250
13	Cabinet médical	Le Puy En Velay	France	43000
14	Cabinet médical	Lempdes sur Allagnon	France	43410
15	Cabinet médical du 38 Bd 1848	Narbonne	France	11000
16	Cabinet de médecine générale	Ondres	France	40440
17	Cabinet de médecine générale	Pont de Buis Les Quimerch	France
18	Cabinet médical du 5 Descente des Oliviers	Restinclières	France	34160
19	Cabinet médical	Saint Nicolas du Pelem	France	22480
20	Groupe médical Tourren	Saint Vincent de Tyrosse	France	40230
21	Cabinet de médecine générale	Saubrigues	France	40230
22	Cabinet médical	Thézan Les Béziers	France	34490
23	Cabinet médical - 39 rue Saint Philibert	Trégunc	France	29910

Sponsors and Collaborators

University Hospital, Brest

Investigators

Principal Investigator: Marie BARAIS, GP, GP department, ERCR SPURBO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT02378779

Other Study ID Numbers:

GETUP

First Posted:

Mar 4, 2015

Last Update Posted:

Oct 19, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by University Hospital, Brest

Premature ejaculation

general practice

sexual dysfunction

Additional relevant MeSH terms:

Premature Ejaculation

Study Results

No Results Posted as of Oct 19, 2020