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Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055624
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Picel, MD, University of California, San Diego

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostatic Hyperplasia, Benign
Enlarged Prostate With Lower Urinary Tract Symptoms
Intervention Device: Embosphere microparticles for prostate artery embolization
Enrollment 9
Recruitment Details Patient were recruited in Interventional Radiology clinic from April 2017 to August 2018.
Pre-assignment Details All patients enrolled were treated in the single treatment arm.
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Period Title: Overall Study
Started [1] 9
Completed [2] 0
Not Completed 9
Reason Not Completed
Study closed             9
[1]
9 patients enrolled in the study and underwent the PAE procedure.
[2]
The device received FDA IDE approval during the study. The study was closed at that time.
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
9 patients enrolled and treated
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  44.4%
>=65 years
5
  55.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
0
   0.0%
Male
9
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were assessed for adverse events during the time period the study was open
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description:

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
3
  33.3%
2.Secondary Outcome
Title Change in International Prostate Symptom Score (IPSS)
Hide Description 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.
Time Frame baseline, 1 month, 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available for 1 participant.
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description:

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
1 month change 16.1  (4.6)
6 month change 18.8  (4.6)
3.Secondary Outcome
Title Change in Post-void Residual (PVR) on Ultrasound
Hide Description 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.
Time Frame baseline, 1 month, 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available for 4 participants.
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description:

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: mL
1 month change -32  (66.5)
6 month change -84.8  (53.5)
4.Secondary Outcome
Title Change in Peak Urinary Flow Rate (Qmax)
Hide Description 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.
Time Frame Baseline, 1 month, 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available for 4 participants
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description:

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: mL/sec
1 month change 2.4  (3.5)
6 month change 6  (6.1)
5.Secondary Outcome
Title Change in International Index of Erectile Dysfunction (IIEF)
Hide Description 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.
Time Frame baseline, 1 month, 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available for 5 participants
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description:

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
1 month change -1.3  (4.7)
6 month change 3  (2.8)
6.Secondary Outcome
Title Change in Prostate Volume (PV)
Hide Description 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.
Time Frame baseline, 1 month, 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not available for 4 participants
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description:

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: mL
1 month change -30.7  (24.1)
6 month change -7.5  (13.1)
Time Frame Adverse event data was collected through the study period. 1 year data was available for the initial treated patients.
Adverse Event Reporting Description Standard definitions used for adverse event and/or serious adverse event.
 
Arm/Group Title Prostate Artery Embolization
Hide Arm/Group Description

Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.

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.

All-Cause Mortality
Prostate Artery Embolization
Affected / at Risk (%)
Total   0/9 (0.00%)    
Hide Serious Adverse Events
Prostate Artery Embolization
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prostate Artery Embolization
Affected / at Risk (%) # Events
Total   3/9 (33.33%)    
Injury, poisoning and procedural complications   
dysuria  [1]  1/9 (11.11%)  1
Renal and urinary disorders   
Urinary retention  [2]  1/9 (11.11%)  1
Skin wound  [3]  1/9 (11.11%)  1
Indicates events were collected by systematic assessment
[1]
Patient experienced painful urination 1.5 days after the procedure. Symptom resolved without treatment.
[2]
Patient experienced urinary retention after the procedure requiring temporary catheter placement.
[3]
Patient experienced a penile skin wound after treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Picel MD
Organization: UCSD
Phone: 619-543-3436
EMail: apicel@stanford.edu
Layout table for additonal information
Responsible Party: Andrew Picel, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03055624    
Other Study ID Numbers: 161719
First Submitted: February 9, 2017
First Posted: February 16, 2017
Results First Submitted: January 19, 2020
Results First Posted: March 31, 2020
Last Update Posted: March 31, 2020