Study Stopped
Multiple reminders were carried out but despite these measures, the GP has not enough participated .
Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
GETUP
1 other identifier
interventional
132
1 country
23
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Typical duration for not_applicable
23 active sites
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
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedStudy Start
First participant enrolled
April 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2018
CompletedOctober 19, 2020
October 1, 2020
2 years
February 3, 2015
October 15, 2020
Conditions
Keywords
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
OTHERThe 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).
Usual care : GP did not trainnd in communication skills
OTHERThe 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
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).
Total attention of the GP to approach the subject of premature ejaculation during all the consultation
Use the humour to approach the subject of premature ejaculation
Take the drama out to approach the subject of premature ejaculation
Question about premature ejaculation during the GP consultation
GP's observation about signs of premature ejaculation
Help for the patient to speak about premature ejaculation
Eligibility Criteria
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
Cabinet médical - 89 Bis Rue de la Calade
Assas, 34820, France
Cabinet médical
Augerolles, 63930, France
Cabinet médical
Avermes, 0300, France
Cabinet médical - Esplanade Mitterrand 5
Bellerive-sur-Allier, 03700, France
Cabinet de médecine générale
Brest, 29200, France
Cabinet du 122 rue Paul Masson
Brest, 29200, France
Cabinet médical Place J. London
Brest, 29200, France
Cabinet médical
Clarensac, 30870, France
Cabinet médical
Fleury, 11560, France
Pôle universitaire de Lanmeur
Lanmeur, 29620, France
Cabinet médical
Le Mayet-de-Montagne, 03250, France
Cabinet médical
Le Puy-en-Velay, 43000, France
Cabinet médical
Lempdes-sur-Allagnon, 43410, France
Cabinet médical du 38 Bd 1848
Narbonne, 11000, France
Cabinet de médecine générale
Ondres, 40440, France
Cabinet de médecine générale
Pont-de-Buis-lès-Quimerch, France
Cabinet médical du 5 Descente des Oliviers
Restinclières, 34160, France
Cabinet médical
Saint-Nicolas-du-Pélem, 22480, France
Groupe médical Tourren
Saint-Vincent-de-Tyrosse, 40230, France
Cabinet de médecine générale
Saubrigues, 40230, France
Cabinet médical
Thézan Les Béziers, 34490, France
Cabinet médical - 39 rue Saint Philibert
Trégunc, 29910, France
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.
PMID: 30419940DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie BARAIS, GP
GP department, ERCR SPURBO
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
- 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
- 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
All collected data that underlie results in a publication