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

NCT ID: NCT02378779

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-22

Study Completion Date

2018-04-22

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 .
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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 .

Study Groups

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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).

Group Type OTHER

Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)

Intervention Type 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 attention

Intervention Type OTHER

Total attention of the GP to approach the subject of premature ejaculation during all the consultation

Humour

Intervention Type OTHER

Use the humour to approach the subject of premature ejaculation

Take the drama out

Intervention Type OTHER

Take the drama out to approach the subject of premature ejaculation

Question about premature ejaculation

Intervention Type OTHER

Question about premature ejaculation during the GP consultation

Symptoms of premature ejaculation

Intervention Type OTHER

GP's observation about signs of premature ejaculation

Help to verbalize

Intervention Type OTHER

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

Group Type OTHER

Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Total attention

Total attention of the GP to approach the subject of premature ejaculation during all the consultation

Intervention Type OTHER

Humour

Use the humour to approach the subject of premature ejaculation

Intervention Type OTHER

Take the drama out

Take the drama out to approach the subject of premature ejaculation

Intervention Type OTHER

Question about premature ejaculation

Question about premature ejaculation during the GP consultation

Intervention Type OTHER

Symptoms of premature ejaculation

GP's observation about signs of premature ejaculation

Intervention Type OTHER

Help to verbalize

Help for the patient to speak about premature ejaculation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie BARAIS, GP

Role: PRINCIPAL_INVESTIGATOR

GP department, ERCR SPURBO

Locations

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Cabinet médical

Ambert, , France

Site Status

Cabinet médical - 89 Bis Rue de la Calade

Assas, , France

Site Status

Cabinet médical

Augerolles, , France

Site Status

Cabinet médical

Avermes, , France

Site Status

Cabinet médical - Esplanade Mitterrand 5

Bellerive-sur-Allier, , France

Site Status

Cabinet de médecine générale

Brest, , France

Site Status

Cabinet du 122 rue Paul Masson

Brest, , France

Site Status

Cabinet médical Place J. London

Brest, , France

Site Status

Cabinet médical

Clarensac, , France

Site Status

Cabinet médical

Fleury, , France

Site Status

Pôle universitaire de Lanmeur

Lanmeur, , France

Site Status

Cabinet médical

Le Mayet-de-Montagne, , France

Site Status

Cabinet médical

Le Puy-en-Velay, , France

Site Status

Cabinet médical

Lempdes-sur-Allagnon, , France

Site Status

Cabinet médical du 38 Bd 1848

Narbonne, , France

Site Status

Cabinet de médecine générale

Ondres, , France

Site Status

Cabinet de médecine générale

Pont-de-Buis-lès-Quimerch, , France

Site Status

Cabinet médical du 5 Descente des Oliviers

Restinclières, , France

Site Status

Cabinet médical

Saint-Nicolas-du-Pélem, , France

Site Status

Groupe médical Tourren

Saint-Vincent-de-Tyrosse, , France

Site Status

Cabinet de médecine générale

Saubrigues, , France

Site Status

Cabinet médical

Thézan Les Béziers, , France

Site Status

Cabinet médical - 39 rue Saint Philibert

Trégunc, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30419940 (View on PubMed)

Other Identifiers

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GETUP

Identifier Type: -

Identifier Source: org_study_id

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