Trial Outcomes & Findings for Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH) (NCT NCT02026908)
NCT ID: NCT02026908
Last Updated: 2024-11-18
Results Overview
The number and the severity of adverse events will be recorded to evaluate safety. Events will be reported by subjects and the severity of events will be graded using the following scale: Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death
COMPLETED
NA
45 participants
5 years
2024-11-18
Participant Flow
All patients were evaluated and followed by a multidisciplinary team including urology and interventional radiology.
Participant milestones
| Measure |
Prostate Artery Embolization
There is only one arm of this study where patients receive Prostate Artery Embolization
Prostate Artery Embolization: Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
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|---|---|
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Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prostate Artery Embolization
n=45 Participants
There is only one arm of this study where patients receive Prostate Artery Embolization
Prostate Artery Embolization: Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
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26 Participants
n=45 Participants
|
|
Age, Continuous
|
67 years
n=45 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=45 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=45 Participants
|
|
Length of BPH symptoms (years)
|
6.4 years
n=45 Participants
|
|
Mean Total Prostate Volume
|
99 cc
n=45 Participants
|
|
BUN (mg/dl)
|
19 mg/dl
n=45 Participants
|
|
Creatinine (mg/dl)
|
1.0 mg/dl
n=45 Participants
|
|
International Normalized Ratio (INR)
|
1.0 ratio
n=45 Participants
|
|
PSA (ng/ml)
|
3.4 ng/ml
n=45 Participants
|
|
percentage of Free PSA
|
24.1 percentage
n=45 Participants
|
|
Subjects with Abnormal Screening Urinalysis (RBCs) >4 per high Power field
|
11 participants
n=45 Participants
|
|
Subjects with Abnormal Screening Urinalysis (WBCs) >5 per high Power Field
|
22 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 5 yearsThe number and the severity of adverse events will be recorded to evaluate safety. Events will be reported by subjects and the severity of events will be graded using the following scale: Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death
Outcome measures
| Measure |
Prostate Artery Embolization
n=45 Participants
There is only one arm of this study where patients receive Prostate Artery Embolization
Prostate Artery Embolization: Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
|
|---|---|
|
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
Grade 1 AE Mild
|
6 events
|
|
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
Grade 2 AE Moderate
|
10 events
|
|
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
Grade 3 AE Severe
|
1 events
|
|
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
Grade 4 AE Life Threatening
|
0 events
|
|
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
Grade 5 AE Fatal
|
0 events
|
SECONDARY outcome
Timeframe: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 yearsPopulation: Not all participants completed the questionnaire at all time points.
Questionnaire-IPSS has 7 questions. Answer choices are as follows. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. Scores can range from 0-35 with 0 being the better outcome and 35 the worst outcome. Question 1-6 0-Not at all 1. Less than 1 time in 5 2. Less than half the time 3. About half the time 4. More than half the time 5. Almost always Question 7 0-None 1-1 time 2-2 times 3-3 times 4-4 times 5-5 or more times
Outcome measures
| Measure |
Prostate Artery Embolization
n=45 Participants
There is only one arm of this study where patients receive Prostate Artery Embolization
Prostate Artery Embolization: Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
|
|---|---|
|
Change in International Prostate Symptom Score (IPSS)
Baseline
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23.6 score on a scale
Standard Deviation 6.1
|
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Change in International Prostate Symptom Score (IPSS)
1 month follow up
|
12 score on a scale
Standard Deviation 5.9
|
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Change in International Prostate Symptom Score (IPSS)
3 month Follow up
|
10.2 score on a scale
Standard Deviation 6.0
|
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Change in International Prostate Symptom Score (IPSS)
6 month follow up
|
11.0 score on a scale
Standard Deviation 7.6
|
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Change in International Prostate Symptom Score (IPSS)
12 month follow up
|
12.4 score on a scale
Standard Deviation 8.4
|
|
Change in International Prostate Symptom Score (IPSS)
2 year follow up
|
10.6 score on a scale
Standard Deviation 6.78
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Change in International Prostate Symptom Score (IPSS)
3 year follow up
|
8.3 score on a scale
Standard Deviation 6.9
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Change in International Prostate Symptom Score (IPSS)
4 year follow up
|
10.6 score on a scale
Standard Deviation 6.5
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Change in International Prostate Symptom Score (IPSS)
5 year follow up
|
11.1 score on a scale
Standard Deviation 8.65
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SECONDARY outcome
Timeframe: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 yearsPopulation: Not all participants completed this score at all data points.
Questionnaire The total score ranges from 0-6 with 0 being the best outcome and 6 being the worst outcome. Questionnaire- answers choices are as follows: 0- Delighted 1. Pleased 2. Mostly Satisfied 3. Mixed about equality satisfied and dissatisfied 4. Mostly Dissatisfied 5. Unhappy 6. Terrible
Outcome measures
| Measure |
Prostate Artery Embolization
n=45 Participants
There is only one arm of this study where patients receive Prostate Artery Embolization
Prostate Artery Embolization: Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
|
|---|---|
|
Change in Quality of Life (QOL) Bother Question
Baseline
|
4.8 score on a scale
Standard Deviation 0.9
|
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Change in Quality of Life (QOL) Bother Question
1 month follow up
|
2.6 score on a scale
Standard Deviation 1.6
|
|
Change in Quality of Life (QOL) Bother Question
3 month follow up
|
2.4 score on a scale
Standard Deviation 1.6
|
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Change in Quality of Life (QOL) Bother Question
6 month follow up
|
2.3 score on a scale
Standard Deviation 1.7
|
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Change in Quality of Life (QOL) Bother Question
12 month follow up
|
2.6 score on a scale
Standard Deviation 1.6
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Change in Quality of Life (QOL) Bother Question
2 year follow up
|
1.9 score on a scale
Standard Deviation 1.4
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Change in Quality of Life (QOL) Bother Question
3 year follow up
|
1.5 score on a scale
Standard Deviation 1.2
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Change in Quality of Life (QOL) Bother Question
4 year follow up
|
2.2 score on a scale
Standard Deviation 1.5
|
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Change in Quality of Life (QOL) Bother Question
5 year follow up
|
2.1 score on a scale
Standard Deviation 1.4
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SECONDARY outcome
Timeframe: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 yearsPopulation: Not all participants answered this questionnaire at all data points.
Questionnaire The BPH Impact Index is to assess the impact of BPH symptoms on patient health and functioning. It is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.The BII is an evaluative index useful in measuring the magnitude of change in the impact of BPH-LUTS within a person over time. Scores range from 0-13 with 0 being the best outcome and 13 being the worst. Questionnaire- consists of 4 questions; answer choices are as follows Question 1: 0-none, 1-only a little, 2-some, 3-a lot Question 2: 0-none, 1-only a little, 2-some, 3-a lot Question 3: 0-not at all bothersome, 1- bothers me a little, 2-bothers me some, 3-bothers me a lot Question 4: 0-none of the time, 1- a little of the time, 2- some of the time, 3-most of the time, 4-all of the time
Outcome measures
| Measure |
Prostate Artery Embolization
n=45 Participants
There is only one arm of this study where patients receive Prostate Artery Embolization
Prostate Artery Embolization: Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
|
|---|---|
|
Change in Benign Prostatic Hyperplasia (BPH) Impact Index
Baseline
|
7.9 score on a scale
Standard Deviation 2.4
|
|
Change in Benign Prostatic Hyperplasia (BPH) Impact Index
1 month follow up
|
3.8 score on a scale
Standard Deviation 2.8
|
|
Change in Benign Prostatic Hyperplasia (BPH) Impact Index
3 month follow up
|
2.3 score on a scale
Standard Deviation 2.5
|
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index
6 month follow up
|
2.5 score on a scale
Standard Deviation 2.9
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index
12 month follow up
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3.4 score on a scale
Standard Deviation 3.1
|
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index
2 year follow up
|
2.1 score on a scale
Standard Deviation 2.2
|
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index
3 year follow up
|
2.0 score on a scale
Standard Deviation 2.2
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index
4 year follow up
|
2.2 score on a scale
Standard Deviation 1.7
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index
5 year follow up
|
2.7 score on a scale
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 yearsPopulation: Low numbers of participants for the 12 month follow and later follow up visits are attributed to COVID when no visits were being made in person. Q max was not requied at the 6 month visit which is why no participates have data for this time point. no participants returned for the 5 year follow up for an in person visit.
Measure of urine flow rate. Q max = max flow rate. Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements
Outcome measures
| Measure |
Prostate Artery Embolization
n=45 Participants
There is only one arm of this study where patients receive Prostate Artery Embolization
Prostate Artery Embolization: Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
|
|---|---|
|
Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
Baseline
|
5.8 ml/second
Standard Deviation 1.0
|
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Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
1 month follow up
|
12.4 ml/second
Standard Deviation 6.8
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Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
3 month follow up
|
15.3 ml/second
Standard Deviation 12.3
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Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
1 year follow up
|
12.6 ml/second
Standard Deviation 12.1
|
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Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
2 year follow up
|
12.4 ml/second
Standard Deviation 6.7
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Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
3 year follow up
|
9.0 ml/second
Standard Deviation 6.7
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Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
4 year follow up
|
3.1 ml/second
Standard Deviation 0
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Adverse Events
Prostate Artery Embolization
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Samdeep Mouli MD
Northwestern University/Northwestern Memorial Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place