Bariatric SurgeryBARIASSONCT03547765
Sexual Health of Obese Men Before and After Bariatric Surgery.
An observational study of Bariatric Surgery, run by University Hospital, Bordeaux at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bariatric Surgery
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jul 2018to 23 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- inclusion criteria not satisfied
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Mutualiste de Pessac
Pessac, 33600
Hôpital Haut-Lévêque - groupe hospitalier Sud
Pessac, 33600
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery
- Keywords
- Obesity, Sexual Dysfunction
- Medical subject headings
- Obesity, Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 month after inclusion day
Secondary outcomes (3)
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
Measured: At 12 month after inclusion day
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
Measured: At 12 month after inclusion day
Correlation between Beck Depression Inventory (BDI) score and Male Health Sexual Questionnaire (MHSQ) score
Correlation investigation between BDI score and MHSQ score
Measured: At 12 month after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start2 Jul 2018
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547765
- Sponsor's protocol ID
- CHUBX 2018/06
- Acronym
- BARIASSO
- Status last verified
- Jul 2023
- First submitted
- 24 May 2018
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sexual Health of Obese Men Before and After Paresis Bariatric Surgery. Prospective Multicentre Study.
- ClinicalTrials.gov ID
- NCT03547765
- Acronym / sponsor ID
- BARIASSO / CHUBX 2018/06
- Conditions
- Bariatric Surgery
- Keywords
- Obesity, Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- inclusion criteria not satisfied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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 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 between Beck Depression Inventory (BDI) score and Male Health Sexual Questionnaire (MHSQ) score
Time frame: At 12 month after inclusion day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average of Male Health Sexual Questionnaire (MHSQ) score (time frame: At 12 month after inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.