Clinical trial NCT05390203: Sexual Function Before and After Bariatric Surgeries.
Official title: Sexual Function Before and After Bariatric Surgeries.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexual Dysfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Assessing Sexual function before and after bariatric surgeries.
timeFrame: 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:
measure: Penile Duplex Doppler Data, Hormonal Profile Data and patients' demographic data.
timeFrame: Will be assessed preoperatively and 6 months postoperatively.
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Andrology , Assiut University
name: EmadEldin Kamal Ali, PHD
role: STUDY_DIRECTOR
affiliation: Professor of plastic surgery, Assiut University
name: Osama Yassin Mostafa Taha
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Andrology , Assiut University
name: Ahmed Mahmoud Mohamed Abdellah
role: STUDY_CHAIR
References:
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