Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378779
Recruitment Status : Terminated (Multiple reminders were carried out but despite these measures, the GP has not enough participated .)
First Posted : March 4, 2015
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE February 3, 2015
First Posted Date  ICMJE March 4, 2015
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE April 22, 2016
Actual Primary Completion Date April 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
The impact of training general practitioners in communication skills [ Time Frame: Day 0 - 4 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
The number of patients with premature ejaculation in general practice in comparison with usual care. [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
Evaluation of quality of life [ Time Frame: Day 0 - 4 weeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
To assess the difference in quality of life scores between pre and post questionnaire consultation. [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
Official Title  ICMJE Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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 .
Masking: None (Open Label)
Masking Description:
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 .
Primary Purpose: Diagnostic
Condition  ICMJE Premature Ejaculation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).

    Interventions:
    • 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
  • 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

    Intervention: Other: Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 23, 2018)
132
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
600
Actual Study Completion Date  ICMJE April 22, 2018
Actual Primary Completion Date April 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02378779
Other Study ID Numbers  ICMJE GETUP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (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
Current Responsible Party University Hospital, Brest
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Brest
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie BARAIS, GP GP department, ERCR SPURBO
PRS Account University Hospital, Brest
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP