Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams

Benign Prostatic Hyperplasia Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

• NCT number: NCT02167009
• Study type: Interventional
• Source: Tampa General Hospital
• Contact: Michelle Hughes, RN
• Email: PAE@tgh.org
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Completion date: May 2020