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Sexual DysfunctionNCT05390203

Sexual Function Before and After Bariatric Surgeries.

An observational study of Sexual Dysfunction, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years, men only
Conditions the study is for
Sexual Dysfunction
What is being tested?
Penile duplex study, Hormonal Assay (Total Testosterone, Prolactin and E2)
How many people
55 participants
Where
No sites listed yet
Study dates
1 Aug 2022to 1 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Patients who are not married;
  • Those with severe psychic illness.
  • And those with congenital or acquired penile problems interfere with sexual intercourse.

Trial locations and contacts

No sites are listed yet.

Mohamed Elbakh, Msc contact

00201021377399

mohamedelbakh2@gmail.com

About this study

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

Read the 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.

Being tested
Penile duplex study, Hormonal Assay (Total Testosterone, Prolactin and E2)
Medical subject headings
Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 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 (1)

  1. 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.

    Measured: Will be assessed preoperatively and 6 months postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390203
Sponsor's protocol ID
ED and Bariatric surgeries
Status last verified
May 2022
First submitted
6 May 2022
Last updated
25 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28292617

  • 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.

    PubMed 25878654

  • 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.

    PubMed 30023076

  • 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.

    PubMed 30619096

  • 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.

    PubMed 19183532

  • 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.

    PubMed 25085222

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

    PubMed 25105982

  • 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.

    PubMed 19726018

  • 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.

    PubMed 23612762

  • 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.

    PubMed 26879634

  • 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.

    PubMed 25361762

Questions about this trial

What is this clinical trial studying?

An observational study of Sexual Dysfunction, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Elbakh, Msc (00201021377399, mohamedelbakh2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessing Sexual function before and after bariatric surgeries. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390203, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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