Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT03055624|
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : March 31, 2020
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Hyperplasia, Benign Enlarged Prostate With Lower Urinary Tract Symptoms||Device: Embosphere microparticles for prostate artery embolization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||February 18, 2019|
|Actual Study Completion Date :||February 18, 2019|
Experimental: Prostate artery embolization
Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.
Device: Embosphere microparticles for prostate artery embolization
Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
- Number of Participants With Adverse Events [ Time Frame: 12 months ]The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.
- Change in International Prostate Symptom Score (IPSS) [ Time Frame: baseline, 1 month, 6 month ]International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.
- Change in Post-void Residual (PVR) on Ultrasound [ Time Frame: baseline, 1 month, 6 month ]PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.
- Change in Peak Urinary Flow Rate (Qmax) [ Time Frame: Baseline, 1 month, 6 month ]Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.
- Change in International Index of Erectile Dysfunction (IIEF) [ Time Frame: baseline, 1 month, 6 month ]IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.
- Change in Prostate Volume (PV) [ Time Frame: baseline, 1 month, 6 month ]Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055624
|United States, California|
|University of California San Diego|
|San Diego, California, United States, 92007|
|Principal Investigator:||Andrew Picel, MD||UCSD Medical Center|