NCT03547765

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3.7 years

First QC Date

May 24, 2018

Last Update Submit

July 18, 2023

Conditions

Keywords

ObesitySexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation between Male Health Sexual Questionnaire (MHSQ) score and Multidimensional Body Self Relations Questionnaire - Appearance Scales (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

    At 12 month after inclusion day

  • Correlation between Beck Depression Inventory (BDI) score and Male Health Sexual Questionnaire (MHSQ) score

    At 12 month after inclusion day

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe 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.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Mutualiste de Pessac

Pessac, 33600, France

Location

Hôpital Haut-Lévêque - groupe hospitalier Sud

Pessac, 33600, France

Location

MeSH Terms

Conditions

ObesitySexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Design

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

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 6, 2018

Study Start

July 2, 2018

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations