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

NCT06527170 | Completed

• 1 other identifier: JagiellonianU-10
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery; Erectile Dysfunction

Keywords

bariatric surgery; erectile dysfunction; obesity

Outcome Measures

Primary Outcomes (1)

• The International Index of Erectile Function score

  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 Outcomes (7)

• Weight loss results

  one year after surgery

• percentage of excess weight loss (%EWL)

  one year after surgery

• percentage of total weight loss (%TWL)

  one year after surgery

• Testoreone (nmol/l)

  immediately before surgery and one year after

• Sex hormone binding (nmol/l)

  immediately before surgery and one year after

Study Arms (1)

Male patients

Male patients undergoing bariatric surgery

Procedure: Sleeve gastrectomy

Interventions

Sleeve gastrectomy PROCEDURE

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

Male patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

Location

Related Publications (3)

• 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.

  PMID: 37086370 BACKGROUND

• 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.

  PMID: 31938930 BACKGROUND

• 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.

  PMID: 17452989 RESULT

MeSH Terms

Conditions

Erectile Dysfunction; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Michał Pędziwiatr, Prof.

  Jagiellonian University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: January 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)