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Sexual Function Before and After Bariatric Surgeries.

Sexual Function Before and After Bariatric Surgeries.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05390203
Enrollment
55
Registered
2022-05-25
Start date
2022-08-01
Completion date
2024-10-01
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction

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.

Interventions

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

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessing Sexual function before and after bariatric surgeries.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.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)

Secondary

MeasureTime frameDescription
Penile Duplex Doppler Data, Hormonal Profile Data and patients' demographic data.Will be assessed preoperatively and 6 months postoperatively.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.

Contacts

Primary ContactMohamed Elbakh, Msc
mohamedelbakh2@gmail.com00201021377399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026