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NCT Number: NCT06527170

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

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.

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Key information

Conditions

Bariatric Surgery Body Weight Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sleeve gastrectomy

Procedure

Each patient undergoes bariatric surgery. Each patient is diagnosed before surgery for erectile dysfunction. Similar tests are done 1 year after

Primary outcomes

  1. 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

Secondary outcomes

  1. Weight loss results

    Time frame: one year after surgery

    weight loss (WL) in kg

  2. percentage of excess weight loss (%EWL)

    Time frame: one year after surgery

    Weight loss results

  3. percentage of total weight loss (%TWL)

    Time frame: one year after surgery

    Weight loss results

  4. Testoreone (nmol/l)

    Time frame: immediately before surgery and one year after

    Laboratory test using blood samples

  5. Sex hormone binding (nmol/l)

    Time frame: immediately before surgery and one year after

    Laboratory test using blood samples

  6. Estradiol (pmol/l)

    Time frame: immediately before surgery and one year after

    Laboratory test using blood samples

  7. luteinizing hormone (mIU/ml)

    Time frame: immediately before surgery and one year after

    Laboratory test using blood samples

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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