Trial Outcomes & Findings for Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia (NCT NCT04398966)
NCT ID: NCT04398966
Last Updated: 2024-05-07
Results Overview
The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
baseline to 6 months following the procedure
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
Prostatic Artery Embolization (PAE) Procedure
This will be a single arm, uncontrolled, non-blinded study of Prostatic Artery Embolization (PAE) using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
HydroPearl® compressible microspheres: Embolic material
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
PAE Procedure
n=12 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 months following the procedurePopulation: Data are reported for all participants with both baseline and Month 6 data.
The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
Outcome measures
| Measure |
PAE Procedure
n=11 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Mean Change in IPSS at 6 Months
|
-9.64 score on a scale
Standard Deviation 9.04
|
SECONDARY outcome
Timeframe: baseline to 6 months following the procedurePopulation: Data are reported for all participants with both baseline and Month 6 data.
The QoL question of the International Prostate Symptom Score (IPSS) is a single question related to the symptoms of the disease benign prostatic hyperplasia (BPH) and ranges from 0 to 6. Lower scores indicate a higher quality of life.
Outcome measures
| Measure |
PAE Procedure
n=11 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Mean Change in Quality of Life Scores at 6 Months
|
-2.00 score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline to 6 months following the procedureUrine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s)
Outcome measures
| Measure |
PAE Procedure
n=10 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Mean Change in Urine Flow
|
0.26 mL/s
Standard Deviation 5.25
|
SECONDARY outcome
Timeframe: baseline to 6 months following the procedureChange in the prostate size measured in grams (g).
Outcome measures
| Measure |
PAE Procedure
n=10 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Mean Change in Prostate Volume
|
-21.10 grams
Standard Deviation 24.63
|
SECONDARY outcome
Timeframe: 6 months following the procedureIndividual percentage of prostate infarcted determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast MRI images and data aggregated for the group to report mean percent.
Outcome measures
| Measure |
PAE Procedure
n=10 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Mean Percent of Prostate Infarcted
|
23 percent entire prostate volume infarcted
Standard Deviation 9.19
|
SECONDARY outcome
Timeframe: up to 3 months following the procedureProportion of participants that experience adverse events considered related to the PAE procedure.
Outcome measures
| Measure |
PAE Procedure
n=12 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Incidence of Treatment Related Adverse Events (Proportion)
|
0.83 proportion of participants
|
SECONDARY outcome
Timeframe: up to 3 months following the procedurePercent of participants that experience adverse events considered related to the PAE procedure.
Outcome measures
| Measure |
PAE Procedure
n=12 Participants
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Incidence of Treatment Related Adverse Events (Percent)
|
83.3 percentage of participants
|
Adverse Events
PAE Procedure
Serious events: 1 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PAE Procedure
n=12 participants at risk
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
General disorders
Failure to Thrive
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
Other adverse events
| Measure |
PAE Procedure
n=12 participants at risk
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material
|
|---|---|
|
Renal and urinary disorders
Dysuria
|
41.7%
5/12 • Number of events 5 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
16.7%
2/12 • Number of events 2 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Cardiac disorders
Exacerbation of Hypertension
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Injury, poisoning and procedural complications
Heaviness in distal left penis
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Musculoskeletal and connective tissue disorders
Heaviness in left lower buttock
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Renal and urinary disorders
Intermittency
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Musculoskeletal and connective tissue disorders
Heat sensation in pelvic area
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
2/12 • Number of events 2 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Gastrointestinal disorders
Rectal bleeding
|
16.7%
2/12 • Number of events 2 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Renal and urinary disorders
Bladder spasm
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Infections and infestations
Strong urinary smell
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Infections and infestations
Strong yellow urine color
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Renal and urinary disorders
Urgency
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Reproductive system and breast disorders
Retrograde ejaculation
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Renal and urinary disorders
Straining
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Skin and subcutaneous tissue disorders
Pain in Groin (Post Embolization Syndrome)
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
General disorders
Fatigue (Post Embolization Syndrome)
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
|
Injury, poisoning and procedural complications
Blotches on Penis
|
8.3%
1/12 • Number of events 1 • From the time of the PAE procedure through 12-Month Follow-Up.
|
Additional Information
Markeela Lipscomb
University of North Carolina at Chapel Hill
Phone: 919-843-3670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place