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CompletedNCT06527170Updated Jul 30, 2024

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

An observational study in Bariatric Surgery and Erectile Dysfunction, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Jagiellonian University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
135
Ages
18 Years to 65 Years
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Bariatric Surgery
  • Erectile Dysfunction

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Keywords

  • bariatric surgery
  • erectile dysfunction
  • obesity
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In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 135 is close to the median of 130 across 115 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
135 participants (actual)
Patient registry
No

Groups and cohorts

  • Male patients

    Male patients undergoing bariatric surgery

    Procedure: Sleeve gastrectomy

Interventions

  • ProcedureSleeve gastrectomy

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

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What researchers measure

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

    Time frame: immediately before surgery and one year after

Secondary outcomes

  1. Weight loss results

    weight loss (WL) in kg

    Time frame: one year after surgery

  2. percentage of excess weight loss (%EWL)

    Weight loss results

    Time frame: one year after surgery

  3. percentage of total weight loss (%TWL)

    Weight loss results

    Time frame: one year after surgery

  4. Testoreone (nmol/l)

    Laboratory test using blood samples

    Time frame: immediately before surgery and one year after

  5. Sex hormone binding (nmol/l)

    Laboratory test using blood samples

    Time frame: immediately before surgery and one year after

  6. Estradiol (pmol/l)

    Laboratory test using blood samples

    Time frame: immediately before surgery and one year after

  7. luteinizing hormone (mIU/ml)

    Laboratory test using blood samples

    Time frame: immediately before surgery and one year after

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Study locations

1 site
  • 2nd Department of General Surgery, Jagiellonian University Medical College
    Kraków, Małopolska 30-688, Poland
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References and documents

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. PubMed 37086370 ↗
  • 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. PubMed 31938930 ↗
  • 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. PubMed 17452989 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06527170
Lead sponsor
Jagiellonian University
Responsible party
Michał Pędziwiatr (Professor, Jagiellonian University) — Principal investigator
First posted
Jul 30, 2024
Start date
Jan 1, 2022
Primary completion
Apr 30, 2024
Completion
May 31, 2024
Last update
Jul 30, 2024

Study contacts

Michał Pędziwiatr, Prof.
study director · Jagiellonian University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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