NCT02378779

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 22, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2018

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

February 3, 2015

Last Update Submit

October 15, 2020

Conditions

Keywords

Premature ejaculationgeneral practicesexual dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 0 - 4 weeks

Secondary Outcomes (1)

  • Evaluation of quality of life

    Day 0 - 4 weeks

Study Arms (2)

Interventional GP : GP trainned in communication skills

OTHER

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)Other: Total attentionOther: HumourOther: Take the drama outOther: Question about premature ejaculationOther: Symptoms of premature ejaculationOther: Help to verbalize

Usual care : GP did not trainnd in communication skills

OTHER

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)

Interventions

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).

Interventional GP : GP trainned in communication skillsUsual care : GP did not trainnd in communication skills

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

Interventional GP : GP trainned in communication skills
HumourOTHER

Use the humour to approach the subject of premature ejaculation

Interventional GP : GP trainned in communication skills

Take the drama out to approach the subject of premature ejaculation

Interventional GP : GP trainned in communication skills

Question about premature ejaculation during the GP consultation

Interventional GP : GP trainned in communication skills

GP's observation about signs of premature ejaculation

Interventional GP : GP trainned in communication skills

Help for the patient to speak about premature ejaculation

Interventional GP : GP trainned in communication skills

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Cabinet médical

Ambert, 63600, France

Location

Cabinet médical - 89 Bis Rue de la Calade

Assas, 34820, France

Location

Cabinet médical

Augerolles, 63930, France

Location

Cabinet médical

Avermes, 0300, France

Location

Cabinet médical - Esplanade Mitterrand 5

Bellerive-sur-Allier, 03700, France

Location

Cabinet de médecine générale

Brest, 29200, France

Location

Cabinet du 122 rue Paul Masson

Brest, 29200, France

Location

Cabinet médical Place J. London

Brest, 29200, France

Location

Cabinet médical

Clarensac, 30870, France

Location

Cabinet médical

Fleury, 11560, France

Location

Pôle universitaire de Lanmeur

Lanmeur, 29620, France

Location

Cabinet médical

Le Mayet-de-Montagne, 03250, France

Location

Cabinet médical

Le Puy-en-Velay, 43000, France

Location

Cabinet médical

Lempdes-sur-Allagnon, 43410, France

Location

Cabinet médical du 38 Bd 1848

Narbonne, 11000, France

Location

Cabinet de médecine générale

Ondres, 40440, France

Location

Cabinet de médecine générale

Pont-de-Buis-lès-Quimerch, France

Location

Cabinet médical du 5 Descente des Oliviers

Restinclières, 34160, France

Location

Cabinet médical

Saint-Nicolas-du-Pélem, 22480, France

Location

Groupe médical Tourren

Saint-Vincent-de-Tyrosse, 40230, France

Location

Cabinet de médecine générale

Saubrigues, 40230, France

Location

Cabinet médical

Thézan Les Béziers, 34490, France

Location

Cabinet médical - 39 rue Saint Philibert

Trégunc, 29910, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Premature EjaculationSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Marie BARAIS, GP

    GP department, ERCR SPURBO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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 .
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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 .
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

March 4, 2015

Study Start

April 22, 2016

Primary Completion

April 22, 2018

Study Completion

April 22, 2018

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL, 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

Locations