Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams
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|ClinicalTrials.gov Identifier: NCT02167009|
Recruitment Status : Recruiting
First Posted : June 18, 2014
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: Embosphere Microspheres||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Prostate Artery Embolization
Device: Embosphere Microspheres
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
- Improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. [ Time Frame: Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167009
|Contact: Michelle Hughes, RN||PAE@tgh.org|
|United States, Florida|
|Tampa General Hospital||Recruiting|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Cliff Davis, MD||Tampa General Hospital|