Innovative treatment for benign prostatic hyperplasia and varicocele

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Paitilla
  Panama City, Provincia de Panamá, Panama Recruiting

Study contacts

• Study coordinator: Yunlong Zhang, Master of Science
• Email: pzhang@rqmplus.com
• Phone: 669-203-9308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sonablate HIFU Registry for Prostate Cancer and BPH

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• Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate

  This study tests whether adding tadalafil to tamsulosin helps men with BPH see better urinary symptoms and quality of life, using two tadalafil doses over 12 weeks.

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• MRI-DTI look at the urethral sphincter ring and prostate base shape

  This imaging study tests how the male urethral internal sphincter ring appears on MRI-DTI and how it relates to prostate base morphology in men undergoing clinically indicated MRI.

  Recruiting Jiangsu Taizhou People's Hospital · Taizhou, Jiangsu · NCT07694752

• Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention

  This study tests whether adding tadalafil to tamsulosin helps men with a first episode of acute urinary retention due to enlarged prostate pass urine without needing a catheter.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07654413

• Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention

  This trial tests whether continuing tamsulosin, increasing its dose, or switching to silodosin helps men with BPH-related acute urinary retention go without a catheter after seven days.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07650968

• Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

  This study tests whether Water Vapor Thermal Therapy (Rezum) or an ejaculation-sparing enucleation procedure better helps sexually active men with bothersome BPH symptoms.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07648888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.