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

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.

Study Overview

• Status: Terminated
• Conditions: Premature Ejaculation
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ambert, France, 63600
    • Cabinet Medical
  • Assas, France, 34820
    • Cabinet médical - 89 Bis Rue de la Calade
  • Augerolles, France, 63930
    • Cabinet Medical
  • Avermes, France, 0300
    • Cabinet Medical
  • Bellerive-sur-Allier, France, 03700
    • Cabinet médical - Esplanade Mitterrand 5
  • Brest, France, 29200
    • Cabinet de médecine générale
  • Brest, France, 29200
    • Cabinet du 122 rue Paul Masson
  • Brest, France, 29200
    • Cabinet médical Place J. London
  • Clarensac, France, 30870
    • Cabinet Medical
  • Fleury, France, 11560
    • Cabinet Medical
  • Lanmeur, France, 29620
    • Pôle universitaire de Lanmeur
  • Le Mayet de Montagne, France, 03250
    • Cabinet Medical
  • Le Puy En Velay, France, 43000
    • Cabinet Medical
  • Lempdes sur Allagnon, France, 43410
    • Cabinet Medical
  • Narbonne, France, 11000
    • Cabinet médical du 38 Bd 1848
  • Ondres, France, 40440
    • Cabinet de médecine générale
  • Pont de Buis Les Quimerch, France
    • Cabinet de médecine générale
  • Restinclières, France, 34160
    • Cabinet médical du 5 Descente des Oliviers
  • Saint Nicolas du Pelem, France, 22480
    • Cabinet Medical
  • Saint Vincent de Tyrosse, France, 40230
    • Groupe médical Tourren
  • Saubrigues, France, 40230
    • Cabinet de médecine générale
  • Thézan Les Béziers, France, 34490
    • Cabinet Medical
  • Trégunc, France, 29910
    • Cabinet médical - 39 rue Saint Philibert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 - 4 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Marie BARAIS, GP, GP department, ERCR SPURBO

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2016
• Primary Completion (Actual): April 22, 2018
• Study Completion (Actual): April 22, 2018

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: sexual dysfunction; Premature ejaculation; general practice
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Premature Ejaculation
• Other Study ID Numbers: GETUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No