NCT02167009

Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams

Phase II, Single Arm Prospective Study to Evaluate Safety and Efficacy of Prostate Artery Embolization in Patients With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tampa General Hospital · Academic / Other
• Sex: Male
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.

Detailed description

This is a phase II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to BPH in patients with prostate size greater than 90 grams that either refuse surgical treatment or are considered poor candidates for traditional surgical therapy. 30 patients will be enrolled in the single treatment arm with follow-up for no less than 12 months. The study will involve a screening period in which patient eligibility will be determined. Once eligibility is confirmed, patients will receive PAE with Embosphere Microspheres within 4 weeks of screening and transrectal ultrasound. After treatment, patients will return for follow-up visits at 1 month, 3 months, 6 months, and 12 months post PAE. At each of these visits, patients will complete IPSS and IIEF questionnaires, undergo a physical exam, and perform a medication review. Repeat TRUS and urodynamic testing will be performed at the 6 month and 12 month post PAE follow-up visit.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Embosphere Microspheres	Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

Timeline

• Start date: 2014-12-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2014-06-18
• Last updated: 2019-09-10

Locations

1 site across 1 country: United States