Clinical trial NCT05679999: Carotid Artery Intima Media Thickness Can Predict the Response to Phosphodiesterase 5 Inhibitors in the Patients With Moderate Erectile Dysfunction
Official title: Carotid Artery Intima Media Thickness Can Predict the Response to Phosphodiesterase 5 Inhibitors in the Patients With Moderate Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction Due to Arterial Disease
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-11
Enrollment: 181
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 40 years of age and under 70 years old with erectile dysfunction

Brief summary: The aim of the present study was to examine the relationship between degrees of erectile dysfunction and carotid artery intima media thickness (CIMT) and its effect on the medical treatment of this disease. Considering that there are vascular pathologies in the etiology, it is important to reveal vascular disorders with CIMT, which is a non-invasive, easily applicable method, and to use it in the grading and treatment of erectile dysfunction.

Detailed description: Background. It is known that vasculogenic disorders play a leading role in the pathophysiology of erectile dysfunction. Cardiovascular risk factors that cause vascular pathologies are also the main actors among the causes of erectile dysfunction. The thickness of the carotid artery intima-media (CIMT) is useful for demonstrate cardiovascular disorders. For this reason, the relationship between CIMT and erectile dysfunction and its use in predicting the response to phosphodiesterase 5 inhibitors (PDE5-I) are encountered in the literature. In this study, the investigators also evaluated the predictive value of CIMT in subgroups of patients according to the severity of erectile dysfunction. Methods. A total of 181 subjects were divided into two groups as patient group (n:150) and control group (n:31). The patients were also divided into subgroups as severe, moderate, mild-moderate, mild erectile dysfunction. Blood tests, carotid ultrasonography and The International Erectile Function Index-5 form (IIEF-5) were applied to all subjects. Tadalafil was administered to each patient. The patients were re-evaluated using the IIEF-5 questionnaire after 2 months of treatment period. According to response to medication, patients were also divided into subgroups as responders and non-responders. Results. Fasting blood glucose, BMI, IIEF score and CIMT were significantly higher in the patient group compared to the control group. The thickness of the carotid artery intima-media thickness was significantly correlated with IIEF-5 score. When the total patient group is evaluated, CIMT value of the responders was significantly lower compared to the non-responders. Carotid artery intima-media was significantly higher in nonresponders of patients with moderate/mild-moderate erectile dysfunction compared to responders, while there were no significant difference in CIMT between responders and non-responders of patients with severe/mild erectile dysfunction. Discussion. In patients with moderate/mild-moderate erectile dysfunction, increased CIMT is associated with an nonresponse to PDE5-I.

Eligibility criteria: Inclusion Criteria:

1. Patients over 40 years of age and under 70 years

Exclusion Criteria:

1. Patients under 40 years of age and over 70 years old
2. Patients whose consent can not be obtained
3. Those with endocrine disease except type II diabetes mellitus
4. Concomitant malignancy

6. Psychiatric problems 7. Previous penile or pelvic surgery/trauma 8. Penile curvature / Peyronie's disease 9. Patients receiving treatment for erectile dysfunction 10. Chronic liver failure 11. Chronic kidney failure 12. Neurological disease 13. Patients with low testosteron level (≤300 ng/dL)

Primary outcomes:
measure: Coexistence of erectile dysfunction and increased CIMT
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
References: