Clinical trial NCT06527170: Improved Erectile Function After Bariatric Surgery: Role of Testosterone and Other Factors
Official title: Improved Erectile Function After Bariatric Surgery: Role of Testosterone and Other Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Erectile Dysfunction
Keywords: bariatric surgery
erectile dysfunction
obesity
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 135
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients undergoing weight loss surgery at high volume bariatric centre. Male patiens who are sexually active

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The International Index of Erectile Function score
timeFrame: immediately before surgery and one year after
Secondary outcomes:
measure: Weight loss results
timeFrame: one year after surgery
measure: percentage of excess weight loss (%EWL)
timeFrame: one year after surgery
measure: percentage of total weight loss (%TWL)
timeFrame: one year after surgery
measure: Testoreone (nmol/l)
timeFrame: immediately before surgery and one year after
measure: Sex hormone binding (nmol/l)
timeFrame: immediately before surgery and one year after
measure: Estradiol (pmol/l)
timeFrame: immediately before surgery and one year after
measure: luteinizing hormone (mIU/ml)
timeFrame: immediately before surgery and one year after
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University Medical College
state: Małopolska
Study officials:
affiliation: Jagiellonian University
name: Michał Pędziwiatr, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.