Sexual Dysfunction MaleFraQBISFMNCT05960682
French Translation and Validation of the Brief Index of Sexual Functioning for Men
An observational study of Sexual Dysfunction Male, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Sexual Dysfunction Male
- What is being tested?
- Questionnaire
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2023to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult mens treated for sexual dysfunction at the Toulouse University Hospital
Who may be able to join
- Adult patient with sexual dysfunction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Sexual Dysfunction Male
- Being tested
- Questionnaire
- Keywords
- Sexual Dysfunction Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Men will complete the French version of the Brief Index of Sexual Functioning for Men paper questionnaire. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to the paper questionnaire
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Jul 2023
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Dysfunction MaleStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric HUYGHE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960682
- Sponsor's protocol ID
- RC31/23/0260
- Acronym
- FraQBISFM
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Translation and Validation of the Brief Index of Sexual Functioning for Men
- ClinicalTrials.gov ID
- NCT05960682
- Acronym / sponsor ID
- FraQBISFM / RC31/23/0260
- Conditions
- Sexual Dysfunction Male
- Keywords
- Sexual Dysfunction Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Other: QuestionnaireMen will complete the French version of the Brief Index of Sexual Functioning for Men paper questionnaire. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult mens treated for sexual dysfunction at the Toulouse University Hospital
Key inclusion criteria (1 listed)
- Adult patient with sexual dysfunction
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients 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). | Other | Questionnaire |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric HUYGHE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction Male, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate to the paper questionnaire (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.