Sexual Function Before and After Bariatric Surgeries.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05390203
Collaborator
(none)
55
26

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Penile duplex study, Hormonal Assay (Total Testosterone, Prolactin and E2)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
55 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sexual Function Before and After Bariatric Surgeries.
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Male
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: EmadEldin Kamal Ali, PHD, Professor of Andrology , Assiut University
  • Principal Investigator: Osama Yassin Mostafa Taha, Professor of plastic surgery, Assiut University
  • Study Chair: Ahmed Mahmoud Mohamed Abdellah, Lecturer of Andrology , Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Abdelrheem Abouelfotouh Abdulrahaman Kenawy Elbakh, Andrology Specialist, Assiut University
ClinicalTrials.gov Identifier:
NCT05390203
Other Study ID Numbers:
  • ED and Bariatric surgeries
First Posted:
May 25, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022