Erectile DysfunctionLIFE-MetS-EDNCT07758842
Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome
A study testing Structured Lifestyle Modification Program in people with Erectile Dysfunction and Metabolic Syndrome, run by Al-Azhar University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction, Metabolic Syndrome
- What is being tested?
- Structured Lifestyle Modification Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesEgypt
- Study dates
- 13 Aug 2026to 24 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Al-Hussein University Hospital, Al-Azhar University, Urology Department
Cairo, 11633
Abul-fotouh Ahmed, abulfotouhahmed7070@gmail.com
- Recruiting
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo
Abul-fotouh Ahmed, +201001066756, abulfotouhahmed@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction, Metabolic Syndrome
- Being tested
- Structured Lifestyle Modification Program
- Medical subject headings
- Erectile Dysfunction, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Lifestyle Modification ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured Lifestyle Modification | Experimental | 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. Receives: Behavioral: Structured Lifestyle Modification Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and six months after initiation of the lifestyle-modification program.
Secondary outcomes (5)
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.
Measured: Baseline and six months
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.
Measured: Baseline and six months.
Change in resistive index
Change in penile resistive index calculated from penile duplex Doppler measurements.
Measured: Baseline and six months.
Change in body weight
Change in body weight measured in kilograms.
Measured: Baseline and six months.
Change in waist circumference
Change in waist circumference measured in centimeters using a standardized measurement method.
Measured: Baseline and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start13 Aug 2026
- Primary completion24 Jul 2027 (estimated)
- Study completion24 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will undergo a structured six-month lifestyle-modification program consisting of dietary counseling, advice regarding moderate-intensity aerobic physical activity, weight-management counseling, smoking-cessation counseling when applicable, sleep-hygiene advice, reduction of sedentary behavior, and behavioral reinforcement during follow-up visits.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
- Investigators
- Abul-fotouh Ahmed, MD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758842
- Sponsor's protocol ID
- UroAzhar_14_026
- Acronym
- LIFE-MetS-ED
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07758842
- Acronym / sponsor ID
- LIFE-MetS-ED / UroAzhar_14_026
- Conditions
- Erectile Dysfunction, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 24 Jul 2027 (estimated)
- Study completion
- 24 Nov 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo a structured six-month lifestyle-modification program consisting of dietary counseling, advice regarding moderate-intensity aerobic physical activity, weight-management counseling, smoking-cessation counseling when applicable, sleep-hygiene advice, reduction of sedentary behavior, and behavioral reinforcement during follow-up visits.
| Arm | Type | Receives |
|---|---|---|
| Structured Lifestyle Modification | Experimental | Behavioral: Structured Lifestyle Modification ProgramParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Lifestyle Modification ProgramParticipants 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. | Behavioural | Structured Lifestyle Modification |
Primary outcome
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.
5 secondary outcomes
Change in International Index of Erectile Function-5 / Sexual Health Inventory
Time frame: Baseline and six months
Change in end-diastolic velocity
Time frame: Baseline and six months.
Change in resistive index
Time frame: Baseline and six months.
Change in body weight
Time frame: Baseline and six months.
Change in waist circumference
Time frame: Baseline and six months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abul-fotouh Ahmed, MD principal investigator
Al-Azhar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Lifestyle Modification Program in people with Erectile Dysfunction and Metabolic Syndrome, run by Al-Azhar University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abul-fotouh Ahmed, MD (00201001066756, abulfotouhahmed7070@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in penile peak systolic velocity from baseline to six months (time frame: Baseline and six months after initiation of the lifestyle-modification program.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.