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NCT07758842
Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome
Conditions: Erectile Dysfunction, Metabolic Syndrome
Sex: Male
Ages: 30 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 55
Sponsor: Al-Azhar University
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07758842). StuddyBuddy aggregates publicly available trial information.