Improved Erectile Function After Bariatric Surgery: Role of Testosterone and Other Factors

July 29, 2024 updated by: Michał Pędziwiatr, Jagiellonian University
The prevalence of obesity has risen dramatically worldwide. Beyond its metabolic implications, obesity profoundly impacts sexual health, particularly in males, with erectile dysfunction emerging as a prevalent and distressing comorbidity. Studies show that bariatric surgery alleviates erectile dysfunction. Patients suffering from obesity have lower testosterone levels, which increase after weight-loss surgery. This study aims to investigate the relationship between erectile dysfunction improvement, weight loss and hormonal changes after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent decades, the prevalence of obesity has risen dramatically worldwide, presenting significant public health concerns. Beyond its metabolic implications, obesity profoundly impacts sexual health, particularly in males, with erectile dysfunction (ED) emerging as a prevalent and distressing comorbidity. Obesity exacerbates the risk of ED through complex interplays of physiological and psychological mechanisms. Physiologically, excess adiposity leads to chronic inflammation, endothelial dysfunction, and hormonal imbalances, all of which contribute to impaired vascular health and reduced testosterone levels, key factors in erectile function. Psychologically, body image dissatisfaction and decreased self-esteem associated with obesity can exacerbate sexual performance anxiety and further contribute to ED. Bariatric surgery is an established treatment method for long-term weight loss which also alleviates symptoms of diabetes, hypertension, and other weight-related comorbidities.

Study Type

Observational

Enrollment (Actual)

135

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

  • Poland
    • Małopolska
      • Kraków, Małopolska, Poland, 30-688
        • 2nd Department of General Surgery, Jagiellonian University Medical College

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Male patients undergoing weight loss surgery at high volume bariatric centre. Male patiens who are sexually active

Description

Inclusion Criteria:

  • patients undergoing laparoscopic sleeve gastrectomy who were qualified according to Guidelines of the International Federation for the Surgery of Obesity and Metabolic Disorders

Exclusion Criteria:

  • lack of data during follow-up visit (at 1-year).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male patients
Male patients undergoing bariatric surgery
Procedure: Sleeve gastrectomy
Each patient undergoes bariatric surgery. Each patient is diagnosed before surgery for erectile dysfunction. Similar tests are done 1 year after

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The International Index of Erectile Function score
Time Frame: immediately before surgery and one year after

6 questions from IIEF official questionnare. Each question is score 1-5.

Erectile dysfunction (ED) assessed using a validated tool Patient who scored <25 points were considered for further analysis. Each patient was categorized into severity: 25-30 no ED, 19-24 mild ED, 13-18 mild to moderate ED, 7-12 moderate ED, 0-6 severe ED.

After follow-up, patients with prior ED (<25 IIEF) were assigned to three groups: 1 - no improvement, 2 - symptom alleviation (change in severity category), 3 - ED remission
immediately before surgery and one year after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss results
Time Frame: one year after surgery
weight loss (WL) in kg
one year after surgery
percentage of excess weight loss (%EWL)
Time Frame: one year after surgery
Weight loss results
one year after surgery
percentage of total weight loss (%TWL)
Time Frame: one year after surgery
Weight loss results
one year after surgery
Testoreone (nmol/l)
Time Frame: immediately before surgery and one year after
Laboratory test using blood samples
immediately before surgery and one year after
Sex hormone binding (nmol/l)
Time Frame: immediately before surgery and one year after
Laboratory test using blood samples
immediately before surgery and one year after
Estradiol (pmol/l)
Time Frame: immediately before surgery and one year after
Laboratory test using blood samples
immediately before surgery and one year after
luteinizing hormone (mIU/ml)
Time Frame: immediately before surgery and one year after
Laboratory test using blood samples
immediately before surgery and one year after

Collaborators and Investigators

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

Sponsor

Jagiellonian University

Investigators

  • Study Director: Michał Pędziwiatr, Prof., Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2022

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JagiellonianU-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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