- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03547765
Sexual Health of Obese Men Before and After Bariatric Surgery. (BARIASSO)
Assessment of Sexual Health of Obese Men Before and After Paresis Bariatric Surgery. Prospective Multicentre Study.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Pessac, France, 33600
- Clinique mutualiste de Pessac
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Pessac, France, 33600
- Hôpital Haut-Lévèque - Groupe Hospitalier SUD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average of Male Health Sexual Questionnaire (MHSQ) score
Time Frame: At 12 month after inclusion day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between Male Health Sexual Questionnaire (MHSQ) score and Multidimensional Body Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) score
Time Frame: At 12 month after inclusion day
|
Correlation investigation between MHSQ score and MBSRQ-AS score
|
At 12 month after inclusion day
|
|
Correlation between Beck Depression Inventory (BDI) score and Multidimensional Body Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) score
Time Frame: At 12 month after inclusion day
|
Correlation investigation between MBSRQ-AS score and BDI score
|
At 12 month after inclusion day
|
|
Correlation between Beck Depression Inventory (BDI) score and Male Health Sexual Questionnaire (MHSQ) score
Time Frame: At 12 month after inclusion day
|
Correlation investigation between BDI score and MHSQ score
|
At 12 month after inclusion day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHUBX 2018/06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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