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Endothelial Markers and Tadalafil Response

19 augusti 2026 uppdaterad av: Abul-fotouh Ahmed, Al-Azhar University

Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction

This prospective cohort study will recruit eligible men attending the Urology/Andrology outpatient clinic. Baseline assessment will include demographic and clinical data, cardiovascular risk assessment, erectile-function questionnaires, routine laboratory investigations, brachial artery flow-mediated dilatation, carotid intima-media thickness, and selected circulating endothelial biomarkers including endothelin-1, nitrite/nitrate, high-sensitivity C-reactive protein, soluble vascular cell adhesion molecule-1, and soluble intercellular adhesion molecule-1. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function, adherence, and adverse events will be assessed during follow-up. The primary outcome will be clinical response at 12 weeks, defined as an improvement of at least 4 points in the IIEF-EF domain together with a positive response to the Global Assessment Question.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Erectile dysfunction is a common male sexual disorder and is often associated with endothelial dysfunction, impaired nitric oxide bioavailability, inflammation, arterial stiffness, and subclinical atherosclerosis. Because penile arteries are relatively small, vasculogenic erectile dysfunction may appear before overt cardiovascular disease. Brachial artery flow-mediated dilatation reflects endothelial-dependent vasodilation, carotid intima-media thickness reflects structural vascular change, and circulating endothelial biomarkers may provide additional information about endothelial injury and inflammation.

This prospective observational cohort study will recruit men with predominantly vasculogenic erectile dysfunction attending the Urology/Andrology outpatient clinic. Baseline demographic, clinical, sexual, laboratory, vascular, and biomarker data will be collected before treatment. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function will be measured again at follow-up using the IIEF-EF domain, IIEF-5/SHIM, and the Global Assessment Question. The primary outcome is clinical response at 12 weeks, defined as an improvement of at least 4 points in IIEF-EF together with a positive Global Assessment Question response. The study will also evaluate whether baseline endothelial dysfunction markers improve prediction of tadalafil response beyond standard clinical variables.

Studietyp

Observationell

Inskrivning (Beräknad)

120

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Egypten
      • Cairo, Egypten
        • Rekrytering
        • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Consecutive adult men with predominantly vasculogenic erectile dysfunction presenting to the Urology/Andrology outpatient clinic at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt, aged 30 to 70 years and eligible for tadalafil 5 mg once daily.

Beskrivning

Inclusion Criteria:

  • Participants must fulfill all of the following:

    • Men aged 30 to 70 years.
    • ED lasting at least 3 months.
    • IIEF-5/SHIM score of 21 or less or clinically documented ED.
    • Clinical features suggesting predominantly vasculogenic ED.
    • Sexually active or willing to attempt sexual intercourse during the study.
    • Able to complete the study questionnaires.
    • Willing to take tadalafil 5 mg once daily for 12 weeks.
    • Able to provide written informed consent.
    • Willing to avoid other ED treatments during the study unless medically necessary.

Exclusion Criteria:

  • Patients will be excluded if they have:

    • ED primarily attributed to psychogenic causes.
    • Predominantly neurogenic ED.
    • Severe untreated hypogonadism likely to be the primary cause of ED.
    • Untreated hyperprolactinemia or another major endocrine disorder.
    • Significant penile anatomical abnormality interfering with intercourse, including severe Peyronie's disease.
    • Previous radical pelvic surgery or pelvic radiotherapy.
    • Active urinary or genital infection.
    • Unstable angina or unstable cardiovascular disease.
    • Recent myocardial infarction or stroke.
    • Uncontrolled hypertension or clinically significant hypotension.
    • Severe renal impairment requiring an alternative tadalafil regimen.
    • Severe hepatic impairment.
    • Active malignancy or expected survival of less than one year.
    • Major psychiatric illness, cognitive impairment or inability to comply with follow-up.
    • Current use of another PDE5 inhibitor or intracavernosal therapy that cannot be discontinued.
    • Concomitant use of organic nitrates, nitric oxide donors or nicorandil.
    • Known hypersensitivity to tadalafil.
    • Participation in another study that may affect erectile function or vascular measurements.
    • Refusal or inability to provide informed consent.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Tadalafil 5 mg once daily
Adult men with predominantly vasculogenic erectile dysfunction who are eligible for tadalafil 5 mg once daily and enrolled in this prospective cohort study.
Läkemedel: Tadalafil 5mg
All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.
Andra namn:
  • PDE5-hämmare

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical response to tadalafil at 12 weeks
Tidsram: 12 weeks
Proportion of participants achieving clinical response, defined as an increase of at least 4 points in the IIEF-EF domain score from baseline together with a positive response to the Global Assessment Question. The IIEF-EF domain scores erectile function on a higher-is-better scale; higher scores indicate better erectile function.
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the International Index of Erectile Function erectile function score.
Tidsram: Baseline to 12 weeks
Change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF). The IIEF-EF domain is a validated erectile function score, with higher values indicating better erectile function.
Baseline to 12 weeks
Change in Erection Hardness Score
Tidsram: Baseline and12 weeks.
Change from baseline in the Erection Hardness Score, a 4-point scale used to assess penile rigidity during erection. Higher scores indicate firmer erections.
Baseline and12 weeks.
Brachial artery flow-mediated dilatation
Tidsram: Baseline
Association between baseline brachial artery flow-mediated dilatation percentage and clinical response to tadalafil. Flow-mediated dilatation is a functional ultrasound-based measure of endothelial-dependent vasodilation; lower values indicate worse endothelial function. Baseline FMD will be evaluated as an independent predictor of treatment response.
Baseline
Carotid intima-media thickness
Tidsram: Baseline
Association between baseline mean carotid intima-media thickness and clinical response to tadalafil. Carotid intima-media thickness is a structural ultrasound marker of subclinical atherosclerosis; higher values indicate more advanced vascular wall thickening. Baseline CIMT will be evaluated as an independent predictor of treatment response.
Baseline
Serum endothelin-1 level
Tidsram: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Serum nitrite/nitrate level
Tidsram: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Serum high-sensitivity C-reactive protein
Tidsram: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Adverse events during tadalafil treatment
Tidsram: Throughout the 12-week treatment period.
Number and type of treatment-emergent adverse events occurring during 12 weeks of tadalafil 5 mg once-daily therapy.
Throughout the 12-week treatment period.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Al-Azhar University

Utredare

  • Huvudutredare: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 augusti 2026

Primärt slutförande (Beräknad)

1 augusti 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

16 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

16 augusti 2026

Första postat (Faktisk)

19 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UroAzhar_18_026

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