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
-
-
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
|
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
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
- Malczak P, Wysocki M, Pisarska-Adamczyk M, Strojek J, Rodak H, Lastovetskyi I, Pedziwiatr M, Major P. Influence of Bariatric Surgery on Erectile Dysfunction-a Systematic Review and Meta-Analysis. Obes Surg. 2023 Jun;33(6):1652-1658. doi: 10.1007/s11695-023-06572-9. Epub 2023 Apr 22.
- Arolfo S, Scozzari G, Di Benedetto G, Vergine V, Morino M. Surgically induced weight loss effects on sexual quality of life of obese men: a prospective evaluation. Surg Endosc. 2020 Dec;34(12):5558-5565. doi: 10.1007/s00464-019-07356-y. Epub 2020 Jan 14.
- Cheng JY, Ng EM. Body mass index, physical activity and erectile dysfunction: an U-shaped relationship from population-based study. Int J Obes (Lond). 2007 Oct;31(10):1571-8. doi: 10.1038/sj.ijo.0803639. Epub 2007 Apr 24.
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.