Lifestyle changes to improve erectile function in men with metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm study tests whether a structured six-month lifestyle-modification program can improve penile hemodynamics and erectile function in adult men with metabolic syndrome-associated ED. Participants receive individualized dietary guidance, aerobic exercise recommendations, weight-management strategies, smoking-cessation support when relevant, sleep and sedentary-behavior advice, and ongoing behavioral reinforcement. Assessments include erectile-function testing, penile duplex Doppler ultrasonography after vasoactive agent administration, body measurements, and selected laboratory parameters at baseline and after six months. The primary hypothesis is that the program will improve peak systolic velocity and erectile-function scores compared with baseline.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men aged 30-65 years.
* Erectile dysfunction present for at least six months.
* International Index of Erectile Function-5 score of 21 or less.
* Metabolic syndrome diagnosed according to the International Diabetes Federation criteria.
* Sexually active participants in a stable sexual relationship.
* Willingness and ability to participate in the six-month lifestyle-modification program.
* Ability to provide written informed consent.

Exclusion Criteria:

* Erectile dysfunction primarily attributable to neurogenic, psychogenic, hormonal, or postsurgical causes.
* Severe hypogonadism requiring immediate testosterone-replacement therapy.
* Use of phosphodiesterase type 5 inhibitors, intracavernosal injections, vacuum erection devices, or other erectile-dysfunction treatment that cannot be discontinued before baseline assessment.
* Significant penile anatomical abnormality that may interfere with penile duplex Doppler assessment, including Peyronie disease.
* Previous pelvic surgery or pelvic radiotherapy likely to affect erectile function.
* Severe or unstable cardiovascular disease that precludes sexual activity or participation in exercise-based lifestyle modification.
* Uncontrolled diabetes mellitus, defined in the protocol as HbA1c greater than 10%.
* Uncontrolled hypertension despite medical therapy.
* Severe renal or hepatic impairment.
* Active malignancy or life expectancy of less than one year.
* Major psychiatric illness, cognitive impairment, or inability to comply with study procedures or follow-up.
* Inability or refusal to provide written informed consent.

Where it's running

• Al-Hussein University Hospital, Al-Azhar University, Urology Department
  Cairo, Egypt Recruiting
• Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
  Cairo, Egypt Recruiting

Study contacts

• Principal investigator: Abul-fotouh Ahmed, MD — Al-Azhar University
• Study coordinator: Abul-fotouh Ahmed, MD
• Email: abulfotouhahmed7070@gmail.com
• Phone: 00201001066756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.