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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05960682
Other study ID # RC31/23/0260
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 31, 2024
Est. completion date January 31, 2025

Study information

Verified date November 2023
Source University Hospital, Toulouse
Contact Eric HUYGHE, MD
Phone 05 61 77 22 33
Email huyghe.e@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 1
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