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

• ClinicalTrials.gov Identifier: NCT02378779
• Recruitment Status: Terminated
• First Posted: March 4, 2015
• Last Update Posted: October 19, 2020
• Sponsor: University Hospital, Brest
• Information provided by (Responsible Party): University Hospital, Brest

Tracking Information

• First Submitted Date: February 3, 2015
• First Posted Date: March 4, 2015
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: April 22, 2016
• Actual Primary Completion Date: April 22, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: March 3, 2015): The number of patients with premature ejaculation in general practice in comparison with usual care. [ Time Frame: 4 weeks ]

Current Secondary Outcome Measures (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 (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: Consultations Reason for Genital, Urinary or Psychological Humans in General Practice
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Premature Ejaculation

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 23, 2018): 132
• Original Estimated Enrollment (submitted: March 3, 2015): 600
• Actual Study Completion Date: April 22, 2018
• Actual Primary Completion Date: April 22, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02378779
• Other Study ID Numbers: GETUP
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: University Hospital, Brest
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marie BARAIS, GP; GP department, ERCR SPURBO

• PRS Account: University Hospital, Brest
• Verification Date: October 2020