NCT05960682

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

July 17, 2023

Last Update Submit

December 23, 2025

Conditions

Keywords

Sexual Dysfunction Male

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Questionnaire

Men will complete the French version of the Brief Index of Sexual Functioning for Men paper questionnaire.

Other: Questionnaire

Interventions

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).

Questionnaire

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsQuestionnary oly for men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult mens treated for sexual dysfunction at the Toulouse University Hospital

You may qualify if:

  • Adult patient with sexual dysfunction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse Hospital

Toulouse, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eric HUYGHE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 27, 2023

Study Start

July 15, 2023

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations