Sexual Function Before and After Bariatric Surgeries.

Sexual Dysfunction Clinical Trial

Official title:

Sexual Function Before and After Bariatric Surgeries.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05390203
• Other study ID #: ED and Bariatric surgeries
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Mohamed Elbakh, Msc
• Phone: 00201021377399
• Email: mohamedelbakh2[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Obesity is a worldwide prevalent problem which is currently considered a pandemic disease. It is intimately related to several comorbidities that negatively impact physical and mental health. Male sexual dysfunction is not uncommon in people with obesity. This could be attributed to many obesity-associated conditions as diabetes mellitus (DM), hypertension (HTN), and mental and social impairment. Obesity indirectly affects male sexual function by inducing many comorbidities associated with sexual dysfunction. Obesity is also a complex endocrine disorder that can independently alter sexual function through the disruption of various sex hormones. Men with morbid obesity often suffer from deep but reversible sexual dysfunction. Several managements have been introduced to deal with obesity. Dietary intervention, medications, physical exercise are widely used in case of mild and moderate obesity. Meanwhile, bariatric surgery has become the most effective treatment strategy for morbid obese patients which can bring great weight reduction and is expected to ameliorate the comorbidities. Mora et al.'s prospective study showed a bariatric surgery-related significant increase in the IIEF score at 1 year postoperatively. This was found also by the Groutz et al. and Kun et al. However, in a retrospective study by Rosenblatt et al., there was no significant increase in the IIEF scores following RYGB surgery in 23 male patients. Similarly, Sarwer et al., in their prospective study, found that despite the increased postoperative IIEF scores, this difference lied out of significance except for the overall satisfaction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients who are not married;

• Those with severe psychic illness.

• And those with congenital or acquired penile problems interfere with sexual intercourse.

Related Conditions & MeSH terms

• Sexual Dysfunction

Intervention

Diagnostic Test:
• Penile duplex study, Hormonal Assay (Total Testosterone, Prolactin and E2)
we will do penile duplex and hormonal profile preoperatively and 6 months postoperatively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (11)

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Penile Duplex Doppler Data, Hormonal Profile Data and patients' demographic data.	we will assess Weight by kilogram, Height by centimeter and BMI by Kg/m2. Our patients are candidate for bariatric surgeries when they have BMI = 40 kg/m2 or = 35 kg/m2 with comorbidities.; Normal values for Total testesterone is from 1.6 to 7.8 ng/ml. Normal values for Prolactin is less than 20 ng/ml. Normal values for Estradiol (E2) is up to 39.8 pg/ml.	Will be assessed preoperatively and 6 months postoperatively.