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

Abstract

Background: Premature ejaculation (PE) is the most common sexual dysfunction among men. According to patients, the general practitioner (GP) is the appropriate professional with whom to discuss this issue. However, few patients receive the medical help needed because GPs find it difficult to talk to their patients about sex. A previous qualitative study provided six strategies described by GPs who had tackled the topic during consultation. A pilot study showed that using one of these strategies after a training course led to an increase in the rate of consultations where the topic was raised: an increase from 6.6 to 30.8%. The aim of this study is to compare whether training in communication skills with these six strategies is more effective than usual care on the incidence of patients bringing up the topic of PE with their GP.

Methods: A cluster randomised controlled trial, stratified over four areas comparing an intervention group, which will receive the six strategies training session, and a control group, which ensures routine medical care. The primary outcome is to investigate the efficacy of a training in communication skills directed towards this pathology, compared with usual care procedures, on the incidence of patients bringing up the topic of PE with their GP. The secondary objective relates to the variation in the quality of life of patients after having recently addressed the topic of PE. Quality of life will be evaluated using the SF-12 health scale, with scoring filled in by the patient immediately after the consultation and 4 weeks later. The patients suffering from PE will be identified if their score is higher than 9 on the Premature Ejaculation Diagnostic Tool filled in 4 weeks after the consultation. The number of patients necessary to highlight a significant difference between the two groups from 5 to 20% is 101. Therefore, a total of 600 patients is expected, 300 in each arm (40 GPs, 15 patients per GP; risk α = 5%; power = 90%; intra-cluster correlation coefficient ρ = 0.2; Hawthorne effect = 15%; lost-to-follow-up rates for GPs = 10% and for patients = 20%).

Discussion: The implication for practice is the improvement in the quality of patient-centred care within a topic area which encompasses almost 30% of male sex-related complaints.

Trial registration: ClinicalTrials.gov, ID: NCT02378779 . Registered on 3 February 2015.

Keywords: General practice; Premature ejaculation; Sexual dysfunction.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the Comité de Protection de la Personne CPP de Paris Ile de France VII n°15–021. This Central Ethics Committee has approved the study for the various centres (Brittany, Aquitaine, Massif Central, Languedoc-Roussillon-Midi-Pyrénées).

Consent or assent to participate

The GPs will sign a written consent after receiving information, both by e-mail and by post. Participating GPs will introduce the trial to patients. Patients will also receive information sheets. GP participants will discuss the trial with patients in the light of the information provided on the information sheets. Patients will then be able to have an informed discussion with their GP. Patients will sign a written consent after information has been delivered orally, as well as in writing, prior to participating in the study and completing the questionnaires.

Consent for publication

Not applicable.

Protocol amendments

Any modifications to the protocol which may impact on the conduct of the study, potential benefit to the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects, will require a formal amendment to the protocol. Such amendment will be agreed and approved by the Comité de Protection de la Personne CPP de Paris Ile de France VII prior to implementation and notified to the health authorities in accordance with local regulations.

Competing interests

The authors declare that they have no competing interests.

Dissemination policy—trial results

We will ensure that the results are widely disseminated through publication in open-access journals as well as via conference presentations.

Dissemination policy—reproducible research

De-identified data sets will be made public when publishing the trial results.

Publisher’s Note

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Figures

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Study design

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Participant timeline

Fig. 3

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Schedule of study procedures