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OpenTrials
Completed

NCT Number: NCT05960682

French Translation and Validation of the Brief Index of Sexual Functioning for Men

Sexual dysfunction consists of a disorder of the sexual response, either in terms of desire, or in terms of vasocongestion, or in terms of orgasmic response, or in more than one phase of this response :

Sexual dysfunctions are today described by the Diagnostic and Statistical Manual (DSM) V as:

* Disorders of sexual desire or decreased libido * Sexual arousal disorder * Delayed or absent orgasmic disorder * Sexual disorder with pain Moreover, sexual dysfunctions are not without consequences on the life of a couple. The origins of these dysfunctions are multiple, but the result is most of the time the same: fear of failure, feeling of incompetence, anxiety, frustration or misunderstanding.

To date, the scientific community benefits from a few self-administered questionnaires to measure the impact of certain dysfunctions. None takes into account all the dimensions of male sexuality. In Italy, the Brief Index of Sexual Functioning for Men is used. This questionnaire contains 22 items, grouped into 7 areas exploring all of male sexuality: desire, arousal, frequency of activity, receptivity, pleasure/orgasm, relationship satisfaction, problem affecting sexuality. This questionnaire is not currently validated in French, whereas the Brief Index of Sexual Functioning for Women is validated.

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Key information

Age range

18 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

Toulouse Hospital

Toulouse, France

About this study

In this context, the Andrology Committee of the French Association of Urology wishes to create a pilot study with French patients presenting sexual dysfunctions with the aim of validating the questionnaire in French. Patient responses to each item will:

  • to determine if the formulation of the items is understandable by all, or if this is not the case
  • to identify the difficulties it can cause, and their causes. Patients treated for sexual dysfunction will be informed of the possibility of answering a questionnaire and that their data will be recorded for the purpose of studying practices and analyzing the results in an anonymous setting, and confidential via the delivery of the information leaflet dedicated to the study. They will have the opportunity to signify their refusal to participate without risk of modification of the coverage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient with sexual dysfunction

Exclusion criteria

  • Patient refusing to participate
  • Patient with difficulties in understanding the French language.
  • Protected persons referred to in Articles L.1121-6 to L.1121-8 of the Public Health Code

Treatment and study plan

Questionnaire

Other

Patients will complete the French version of the Brief Index of Sexual Functioning for Men (BISFM) paper questionnaire. The BISFM is a self-administered questionnaire. It has 22 questions, grouped into 7 domains allowing a qualitative and quantitative evaluation of the sexual experience: D1 (desire), D2 (excitement), D3 (frequency of activity), D4 (receptivity), D5 (pleasure, orgasm ), D6 (relationship satisfaction), D7 (problems affecting sexuality).

Primary outcomes

  1. Response rate to the paper questionnaire

    Time frame: Day 1

    Answer two sub-questions a) and b) after each item of the scale. These answers will allow to determine if the formulation of the items is understandable by all, or if this is not the case, to identify the difficulties it can cause, and their causes.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: FraQBISFM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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