Sexual Function Before and After Bariatric Surgeries.

NCT05390203 | Unknown

• 1 other identifier: ED and Bariatric surgeries
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess sexual function before and the impact of weight loss after bariatric surgery among obese men with sexual dysfunction.

Conditions

Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Assessing Sexual function before and after bariatric surgeries.

  Assessing Sexual function (Erectile function, Orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) after bariatric surgery by the International Index of Erectile Function (IIEF)-5 questionnaire preoperatively and 6 months postoperatively. International Index of Erectile Function-IIEF-5) as a diagnostic tool for ED. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25)

  We will assess the scores of the questionnaire preoperatively and the change of each score at 6 months postoperatively to evaluate if there are changes after bariatric surgery on sexual function or not.

Secondary Outcomes (1)

• Penile Duplex Doppler Data, Hormonal Profile Data and patients' demographic data.

  Will be assessed preoperatively and 6 months postoperatively.

Interventions

Penile duplex study, Hormonal Assay (Total Testosterone, Prolactin and E2) DIAGNOSTIC_TEST

we will do penile duplex and hormonal profile preoperatively and 6 months postoperatively.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will involve fifty-five obese male patients "those indicated for bariatric surgery" complaining from sexual dysfunction with score ≤ 21 in the International Index of Erectile Function-5 (IIEF-5) questionnaire.

You may qualify if:

• The study will involve fifty-five obese male patients "those indicated for bariatric surgery" complaining from sexual dysfunction with score ≤ 21 in the International Index of Erectile Function-5 (IIEF-5) questionnaire.
• N.B. Indication for bariatric surgeries when they have BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities.

You may not qualify if:

• Patients who are not married;
• Those with severe psychic illness.
• And those with congenital or acquired penile problems interfere with sexual intercourse.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• Meldrum DR, Morris MA, Gambone JC. Obesity pandemic: causes, consequences, and solutions-but do we have the will? Fertil Steril. 2017 Apr;107(4):833-839. doi: 10.1016/j.fertnstert.2017.02.104. Epub 2017 Mar 11.

  PMID: 28292617 BACKGROUND

• Djalalinia S, Qorbani M, Peykari N, Kelishadi R. Health impacts of Obesity. Pak J Med Sci. 2015 Jan-Feb;31(1):239-42. doi: 10.12669/pjms.311.7033.

  PMID: 25878654 BACKGROUND

• Esfahani SB, Pal S. Obesity, mental health, and sexual dysfunction: A critical review. Health Psychol Open. 2018 Jul 12;5(2):2055102918786867. doi: 10.1177/2055102918786867. eCollection 2018 Jul-Dec.

  PMID: 30023076 BACKGROUND

• Di Vincenzo A, Busetto L, Vettor R, Rossato M. Obesity, Male Reproductive Function and Bariatric Surgery. Front Endocrinol (Lausanne). 2018 Dec 18;9:769. doi: 10.3389/fendo.2018.00769. eCollection 2018.

  PMID: 30619096 BACKGROUND

• Dallal RM, Chernoff A, O'Leary MP, Smith JA, Braverman JD, Quebbemann BB. Sexual dysfunction is common in the morbidly obese male and improves after gastric bypass surgery. J Am Coll Surg. 2008 Dec;207(6):859-64. doi: 10.1016/j.jamcollsurg.2008.08.006. Epub 2008 Oct 1.

  PMID: 19183532 BACKGROUND

• Efthymiou V, Hyphantis T, Karaivazoglou K, Gourzis P, Alexandrides TK, Kalfarentzos F, Assimakopoulos K. The effect of bariatric surgery on patient HRQOL and sexual health during a 1-year postoperative period. Obes Surg. 2015 Feb;25(2):310-8. doi: 10.1007/s11695-014-1384-x.

  PMID: 25085222 BACKGROUND

• Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.

  PMID: 25105982 BACKGROUND

• Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, Clegg AJ. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol Assess. 2009 Sep;13(41):1-190, 215-357, iii-iv. doi: 10.3310/hta13410.

  PMID: 19726018 BACKGROUND

• Mora M, Aranda GB, de Hollanda A, Flores L, Puig-Domingo M, Vidal J. Weight loss is a major contributor to improved sexual function after bariatric surgery. Surg Endosc. 2013 Sep;27(9):3197-204. doi: 10.1007/s00464-013-2890-y. Epub 2013 Apr 24.

  PMID: 23612762 BACKGROUND

• Groutz A, Gordon D, Schachter P, Amir H, Shimonov M. Effects of bariatric surgery on male lower urinary tract symptoms and sexual function. Neurourol Urodyn. 2017 Mar;36(3):636-639. doi: 10.1002/nau.22980. Epub 2016 Feb 16.

  PMID: 26879634 BACKGROUND

• Kun L, Pin Z, Jianzhong D, Xiaodong H, Haoyong Y, Yuqian B, Hongwei Z. Significant improvement of erectile function after Roux-en-Y gastric bypass surgery in obese Chinese men with erectile dysfunction. Obes Surg. 2015 May;25(5):838-44. doi: 10.1007/s11695-014-1465-x.

  PMID: 25361762 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• EmadEldin Kamal Ali, PHD

  Professor of Andrology , Assiut University

  STUDY DIRECTOR

• Osama Yassin Mostafa Taha

  Professor of plastic surgery, Assiut University

  PRINCIPAL INVESTIGATOR

• Ahmed Mahmoud Mohamed Abdellah

  Lecturer of Andrology , Assiut University

  STUDY CHAIR

Central Study Contacts

Mohamed Elbakh, Msc

CONTACT

00201021377399; mohamedelbakh2@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 25, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-05