Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-65
SponsorAl-Azhar University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Structured Lifestyle Modification Program
BehavioralParticipants will receive an initial standardized counseling session followed by written lifestyle instructions and repeated monthly reinforcement. The program will target improved diet quality, reduced caloric intake, increased moderate-intensity aerobic activity, weight reduction according to baseline body mass index and waist circumference, smoking cessation when applicable, improved sleep hygiene, and reduced sedentary behavior. Adherence will be assessed using participant self-report and follow-up review over six months.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Structured Lifestyle ModificationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in penile peak systolic velocity from baseline to six months
Change in peak systolic velocity measured in centimeters per second by penile duplex Doppler ultrasonography after intracavernosal vasoactive-agent administration, comparing the baseline value with the six-month post-intervention value.
Time frame
Baseline and six months after initiation of the lifestyle-modification program.Secondary outcomes
1
Change in International Index of Erectile Function-5 / Sexual Health Inventory
Change in total score from baseline to 6 months. Score range 5-25; higher scores indicate better erectile function.
Time frame
Baseline and six months2
Change in end-diastolic velocity
Change in the total score of the International Index of Erectile Function-5 (IIEF-5) questionnaire from baseline to 6 months. The IIEF-5 total score ranges from 5 to 25, with higher scores indicating better erectile function and lower scores indicating greater erectile dysfunction.
Time frame
Baseline and six months.3
Change in resistive index
Change in penile resistive index calculated from penile duplex Doppler measurements.
Time frame
Baseline and six months.4
Change in body weight
Change in body weight measured in kilograms.
Time frame
Baseline and six months.Sponsors and contacts
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Source ClinicalTrials.gov