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TerminatedNCT02378779GETUPUpdated Oct 19, 2020

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

An interventional study of Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool) and Total attention in Premature Ejaculation, sponsored by University Hospital, Brest. Terminated at 23 sites in France. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Multiple reminders were carried out but despite these measures, the GP has not enough participated .
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Premature Ejaculation

Keywords

  • Premature ejaculation
  • general practice
  • sexual dysfunction
03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's enrollment of 132 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (actual)

Study arms

  • 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) · Other: Total attention · Other: Humour · Other: Take the drama out · Other: Question about premature ejaculation · Other: Symptoms of premature ejaculation · Other: Help to verbalize

  • 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)

Interventions

  • OtherQuestionary 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).

  • OtherTotal attention

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

  • OtherHumour

    Use the humour to approach the subject of premature ejaculation

  • OtherTake the drama out

    Take the drama out to approach the subject of premature ejaculation

  • OtherQuestion about premature ejaculation

    Question about premature ejaculation during the GP consultation

  • OtherSymptoms of premature ejaculation

    GP's observation about signs of premature ejaculation

  • OtherHelp to verbalize

    Help for the patient to speak about premature ejaculation

06

What researchers measure

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.

    Time frame: Day 0 - 4 weeks

Secondary outcomes

  1. 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.

    Time frame: Day 0 - 4 weeks

07

Study locations

23 sites
  • 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 Les Quimerch, France
  • Cabinet médical du 5 Descente des Oliviers
    Restinclières, 34160, France
  • Cabinet médical
    Saint Nicolas du Pelem, 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
08

References and documents

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. PubMed 30419940 ↗

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol, Informed consent form

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02378779
Responsible party
Sponsor
First posted
Mar 4, 2015
Start date
Apr 22, 2016
Primary completion
Apr 22, 2018
Completion
Apr 22, 2018
Last update
Oct 19, 2020

Study contacts

Marie BARAIS, GP
principal investigator · GP department, ERCR SPURBO

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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