Varicocele
Conditions
Brief summary
This prospective study will evaluate two different approaches for performing embolization to treat varicocele, a condition in which the veins around the testicle become enlarged. Thirty patients with varicocele will undergo embolization using either a transjugular approach, through a vein in the neck, or a transfemoral approach, through a vein in the groin. The choice of approach will depend on the patient's venous anatomy and the feasibility of the procedure. Patients will be followed up at one and three months after the procedure to assess treatment effectiveness, symptom improvement, and any complications.
Interventions
PROCEDUREPercutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)
Percutaneous varicocele embolization will be performed under fluoroscopic guidance using a transvenous approach, either transfemoral or transjugular, according to the venous anatomy and operator preference. Selective catheterization of the internal spermatic vein will be performed, followed by embolization using N-butyl cyanoacrylate (NBCA) glue. Technical success will be assessed by completion venography demonstrating occlusion of the targeted varicocele veins and absence of significant residual venous reflux.
Sponsors
Sohag University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Male patients aged 16-60 years. 2. Clinically palpable varicocele (Grade II or III) or subclinical varicocele associated with abnormal semen parameters. 3\. Recurrent varicocele following previous surgical treatment. 4. Presence of scrotal pain, testicular atrophy, or infertility attributed to varicocele. 5\. Willingness to participate in the study and provide written informed consent.
Exclusion criteria
\- 1. Secondary varicocele due to a retroperitoneal mass or renal vein obstruction. 2\. Known allergy to iodinated contrast media. 3. Coagulation disorders or contraindications to endovascular procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by the Visual Analog Scale (VAS). | 1 month after the procedure | Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A decrease in the VAS score indicates improvement in pain. The change in VAS score from baseline to 1 month after varicocele embolization will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by the Visual Analog Scale (VAS) at 3 Months. | 3 months after the procedure | Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A decrease in the VAS score indicates improvement in pain. The change in VAS score from baseline to 3 months after varicocele embolization will be assessed. |
| Change in Maximum Diameter of the Pampiniform Plexus Veins on Doppler Ultrasound | 3 months after the procedure | The maximum diameter of the pampiniform plexus veins will be measured using color and spectral Doppler ultrasound before and after varicocele embolization. A decrease in the maximum venous diameter indicates improvement. The change in venous diameter from baseline to 3 months after the procedure will be assessed. |
| Resolution of Venous Reflux on Doppler Ultrasound | 3 months after the procedure | Venous reflux will be assessed using color and spectral Doppler ultrasound. Resolution of reflux will be defined as the absence of demonstrable venous reflux after varicocele embolization. The presence or absence of venous reflux will be assessed at 3 months after the procedure. |
Countries
Egypt
Contacts
CONTACTarsanious Maher adib, MBBCh
Outcome results
None listed