Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome (LIFE-MetS-ED)

August 13, 2026 updated by: Abul-fotouh Ahmed, Al-Azhar University

Penile Hemodynamic Recovery Following a Six-Month Structured Lifestyle Modification Program in Men With Metabolic Syndrome-Associated Erectile Dysfunction: A Prospective Single-Arm Interventional Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective single-arm interventional study will evaluate the effect of a structured six-month lifestyle-modification program on penile hemodynamic parameters and erectile function in adult men with metabolic syndrome-associated erectile dysfunction.

Participants will undergo baseline assessment including demographic and clinical data collection, anthropometric measurements, blood-pressure assessment, erectile-function evaluation using the International Index of Erectile Function-5, selected laboratory investigations, and penile duplex Doppler ultrasonography after intracavernosal administration of a vasoactive agent according to the local institutional protocol.

The lifestyle program will include individualized dietary counseling, recommendations for regular moderate-intensity aerobic physical activity, weight-reduction advice, smoking-cessation counseling for smokers, sleep-hygiene counseling, reduction of sedentary behavior, and behavioral reinforcement during follow-up visits. Participants will be followed monthly for adherence reinforcement and will undergo repeat clinical, laboratory, erectile-function, and penile hemodynamic assessments at six months.

The principal hypothesis is that structured lifestyle modification will improve penile hemodynamic parameters, particularly peak systolic velocity, and will improve erectile-function scores in men with metabolic syndrome-associated erectile dysfunction.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11633
        • Recruiting
        • Al-Hussein University Hospital, Al-Azhar University, Urology Department
        • Contact:
      • Cairo, Egypt
        • Recruiting
        • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Lifestyle Modification
Participants will receive a structured six-month lifestyle-modification program consisting of dietary counseling, moderate-intensity physical-activity advice, weight-management counseling, smoking-cessation counseling when applicable, sleep-hygiene advice, reduction of sedentary behavior, and monthly behavioral reinforcement.
Behavioral: Structured Lifestyle Modification Program
Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in penile peak systolic velocity from baseline to six months
Time Frame: Baseline and six months after initiation of the lifestyle-modification program.
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.
Baseline and six months after initiation of the lifestyle-modification program.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in resistive index
Time Frame: Baseline and six months.
Change in penile resistive index calculated from penile duplex Doppler measurements.
Baseline and six months.
Change in body weight
Time Frame: Baseline and six months.
Change in body weight measured in kilograms.
Baseline and six months.
Change in waist circumference
Time Frame: Baseline and six months.
Change in waist circumference measured in centimeters using a standardized measurement method.
Baseline and six months.
Change in end-diastolic velocity
Time Frame: Baseline and six months.
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.
Baseline and six months.
Change in International Index of Erectile Function-5 / Sexual Health Inventory
Time Frame: Baseline and six months
Change in total score from baseline to 6 months. Score range 5-25; higher scores indicate better erectile function.
Baseline and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Abul-fotouh Ahmed, MD, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2026

Primary Completion (Estimated)

July 24, 2027

Study Completion (Estimated)

November 24, 2027

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 6, 2026

First Posted (Actual)

August 11, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UroAzhar_14_026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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