Sexual Health of Obese Men Before and After Bariatric Surgery. (BARIASSO)

July 18, 2023 updated by: University Hospital, Bordeaux

Assessment of Sexual Health of Obese Men Before and After Paresis Bariatric Surgery. Prospective Multicentre Study.

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pessac, France, 33600
        • Clinique mutualiste de Pessac
      • Pessac, France, 33600
        • Hôpital Haut-Lévèque - Groupe Hospitalier SUD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The sexual dysfunctions are more commonly in the obese men population. There are few data that evaluate the sexual health of this population. We believe that one of the major determinants of sexual health in obese men is the self-image.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

March 23, 2022

Study Completion (Actual)

March 23, 2022

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CHUBX 2018/06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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