Sexual Function Before and After Bariatric Surgeries.

NCT ID: NCT05390203

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-10-01

Brief Summary

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

Detailed 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.

Conditions

Sexual Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdelrheem Abouelfotouh Abdulrahaman Kenawy Elbakh

Andrology Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EmadEldin Kamal Ali, PHD

Role: STUDY_DIRECTOR

Professor of Andrology , Assiut University

Osama Yassin Mostafa Taha

Role: PRINCIPAL_INVESTIGATOR

Professor of plastic surgery, Assiut University

Ahmed Mahmoud Mohamed Abdellah

Role: STUDY_CHAIR

Lecturer of Andrology , Assiut University

Central Contacts

Mohamed Elbakh, Msc

Role: CONTACT

mohamedelbakh2@gmail.com

00201021377399

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

ED and Bariatric surgeries

Identifier Type: -

Identifier Source: org_study_id