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Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome

RecruitingNAAges 30 Years - 65 YearsMaleAl-Azhar University
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In plain words

What the trial is, and whether it could suit you

Metabolic syndrome is associated with erectile dysfunction through obesity, insulin resistance, abnormal blood lipids, high blood pressure, and impaired blood-vessel function. This study will evaluate whether a structured six-month lifestyle-modification program can improve penile blood flow and erectile function in men with metabolic syndrome-associated erectile dysfunction. Eligible participants will receive dietary counseling, exercise guidance, weight-management advice, smoking-cessation counseling when applicable, sleep and sedentary-behavior advice, and repeated behavioral reinforcement. Erectile function, penile blood-flow measurements obtained by penile duplex Doppler ultrasonography, body measurements, and selected metabolic laboratory parameters will be assessed before the program and after six months.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Structured Lifestyle Modification Program
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Where

2 sites
Al-Hussein University Hospital, Al-Azhar University, Urology Department
Cairo, Egypt
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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