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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03547765
Other study ID # CHUBX 2018/06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2, 2018
Est. completion date March 23, 2022

Study information

Verified date July 2023
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Compare Male Health Sexual Questionnaire (MHSQ) before and after bariatric surgery to assess the sexual health of the obese men with a recommended and exhaustive tool. There are few data that evaluate the sexual health of this population.


Description:

The sexual dysfunctions are more commonly in the obese men population. For example, erectile dysfunction is more than twice as common as in the general population. However, the data on sexuality in the broad sense are rarer. The latter are in favor of an inconsistent improvement and use the Brief Male Sexual Function Inventory. The MHSQ is now recommended by the French Urology Association to evaluate more fully male sexuality. Its relatively recent validation explains the few studies referring to. The investigators believe that one of the major determinants of sexual health in obese men is the self-image. The investigators will submit to the patients the male heath sexual questionnaire, the Beck Depression Inventory (BDI) and the Multidimensional Body Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) and collect weight, BMI and age during the classic follow up. The data will be collected during the preoperative assessment as well as 6 months and 12 months postoperatively.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date March 23, 2022
Est. primary completion date March 23, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any male patient eligible for bariatric surgery, the indication of which was decided at a multidisciplinary consultation meeting. - not opposed to research. - benefiting from social security cover. Exclusion Criteria: - inclusion criteria not satisfied

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Clinique Mutualiste de Pessac Pessac
France Hôpital Haut-Lévêque - groupe hospitalier Sud Pessac

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average of Male Health Sexual Questionnaire (MHSQ) score Comparison of MHSQ score before and after bariatric surgery to assess the sexual health of the obese men. MHSQ measures differents aspects of ability to have sexual activities: erection, ejaculation and satisfaction.
MHSQ score varies from 0, extremely embarrassed, to 90, not at all embarrassed.
At 12 month after inclusion day
Secondary Correlation between Male Health Sexual Questionnaire (MHSQ) score and Multidimensional Body Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) score Correlation investigation between MHSQ score and MBSRQ-AS score At 12 month after inclusion day
Secondary Correlation between Beck Depression Inventory (BDI) score and Multidimensional Body Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) score Correlation investigation between MBSRQ-AS score and BDI score At 12 month after inclusion day
Secondary Correlation between Beck Depression Inventory (BDI) score and Male Health Sexual Questionnaire (MHSQ) score Correlation investigation between BDI score and MHSQ score At 12 month after inclusion day
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