Innovative treatment for benign prostatic hyperplasia and varicocele

Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein

This study is testing a new, less invasive surgery for men with benign prostatic hyperplasia and varicoceles to see if it can improve their symptoms and reduce complications compared to traditional methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 75 Years
• Sex: Male
• Sponsor: Vivifi Medical (Industry-sponsored)
• Locations: 1 site (Panama City, Provincia de Panamá)
• Trial ID: NCT06424912 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and feasibility of Vivifi's Treatment, a surgical procedure designed to address benign prostatic hyperplasia (BPH) and clinical varicoceles in men. The approach aims to provide a less invasive alternative to traditional surgical methods that often involve tissue removal or destruction. By focusing on the root cause of BPH, this treatment seeks to improve patient outcomes and reduce complications associated with existing therapies. The study will involve male participants aged 40-75 who meet specific eligibility criteria related to prostate size and urinary symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are males aged 40-75 diagnosed with benign prostatic hyperplasia and clinical varicocele, experiencing significant urinary symptoms.

Not a fit: Patients with a history of invasive prostate interventions or those with severe urinary retention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a safer and more effective option for men suffering from BPH and varicocele.

How similar studies have performed: While there are established treatments for BPH, this specific approach is novel and has not been widely tested in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Male 40-75 years of age
2. Diagnosed with Benign prostatic hyperplasia (BPH)
3. Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
4. Signed the study informed consent form (ICF)
5. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
6. Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar.

Exclusion Criteria:

1. Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
2. Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
3. Prostate with large intravesical median lobe
4. Patients with sub-clinical varicocele
5. Post-void residual volume (PVR) \> 110ml
6. IPSS (International Prostate Symptoms Score) \>24
7. Patients with clinical history of chronic prostatitis.
8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).
9. Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
10. Patients that can not be under general anesthesia
11. Patients on blood thinners, or with coagulation related issues, TTP
12. Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc
13. History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study.
14. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements
15. Subject currently participating in other investigational studies unless approved by the Sponsor in writing

Where this trial is running

Panama City, Provincia de Panamá

• Hospital Paitilla — Panama City, Provincia de Panamá, Panama (Recruiting)

Study contacts

• Study coordinator: Yunlong Zhang, Master of Science

Conditions Benign Prostatic Hyperplasia; Varicocele Grade II; Varicocele Grade III; BPH; Varicocele