Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Sponsor: Northwestern University

 
 
 
 
Cover Page 
 
Study Title:  
Prostatic Artery Embolization (PAE) for Treatment of Signs and 
Symptoms of Benign Prostatic Hyperplasia (BPH) 
 
NCT:  
NCT03052049 
 
Last reviewed by Northwestern University IRB 11/19/2021 
 
Protocol version 12.3.2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
Protocol version 12.3.2019 
Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic 
Hyperplasia (BPH) 
 
 
Title 
Prostatic Artery Embolization (PAE) for Treatment of Signs and 
symptoms of Benign Prostatic Hyperplasia (BPH) 
Short Title 
PAE for BPH 
Protocol Number 
V 12.3.19 
Phase 
Pilot study 
Methodology 
Open labeled, non-randomized feasibility study 
Study Duration 
We estimate it will take approximately 2 years to fully enroll and 
complete the study. 
Study Center(s) 
Single Center, Northwestern: (Northwestern University, Northwestern 
Memorial Hospital and Northwestern Memorial Faculty Foundation) 
Objectives 
Primary Objective: Evaluate the safety of PAE for the treatment of lower 
urinary tract symptoms (LUTS) attributed to BPH. 
Number of Subjects 
30 
Diagnosis and Main 
Inclusion Criteria 
Subjects with LUTS secondary to BPH refractory to/contraindicated for 
medical treatment 
Study Product(s) 
BeadBlock® Embolic Beads, BTG International, given intra-procedurally 
Duration of administration 
Dose given one-time during interventional radiology PAE procedure, 
given by and at the discretion of the interventional radiologist PI or 
SubI’s 
Statistical Methodology 
Descriptive Statistics will be employed. 
 
 
STUDY OBJECTIVES 
Primary Objectives 
Endpoint #1: Patient safety 
The Primary Objective of this pilot study is to evaluate the safety of PAE for the treatment of LUTS 
attributed to BPH. Primary Safety Endpoints include: 

 
 
 
1. 
A reduced incidence and severity of adverse events compared with historical TURP 
morbidity rates. These include genitourinary events (i.e., events associated with the urinary 
tract and/or the surrounding genital region) 
2. 
Damage to the bladder floor, trigone, sphincters, and rectum 
3. 
Incontinence as defined by International Continence Society (ICS) male IS score of at 
least +6 from baseline. 
4. 
Infections 
5. 
Secondary surgical interventions 
6. 
All transient post‐procedure events (i.e. catheter dwelling time) 
7. 
Deaths 
Endpoint #2: Objective clinical endpoints (measured at baseline, 4 weeks, 12 weeks, 6 and 12 months) 
1. 
Change in International Prostate Symptom Score (IPSS) 
2. 
Change in QoL bother question 
3. 
Change in BPH impact index 
4. 
Change in Qmax (peak and total void volume at each followup visit) 
5. 
Change in Post Void Residual (PVR) Volumes: Measure PVR at each follow-up visit to 
monitor impairment or improvement of bladder emptying due to the treatment or disease 
progression 
6. 
Change in Detrusor Muscle Pressure (Pdet) at Peak Urine Flow (Qmax) 
7. 
Change in International Index of Erectile Function (IIEF- EF) domain 
8. 
Change in Male Sexual Health Questionnaire (MSHQ) 
9. 
Change in Prostate Volume 
10. 
Cystoscopic appearance of the prostatic urethra  
Endpoints: 
Preliminary Safety (Primary Endpoints) will be assessed during treatment and at post-treatment 
intervals of 1, 3, 6 and 12 months. Preliminary effectiveness (Secondary Endpoint) will be 
evaluated based on International Prostate System Score (IPSS) and cystoscopic visualization of 
the subject’s urethra, prostate and bladder based on the timeline listed in the protocol. 
Study Design 
This pilot study will be a single center, open labeled, non-randomized feasibility study to 
evaluate the initial safety of the PAE for the treatment of symptomatic BOO. 30 adult male 
subjects will be enrolled in this study. 
 

 
 
 
Statistical Analysis 
General considerations: continuous variables will be summarized as n, mean, standard deviation, median, 
minimum and maximum. Categorical variables will be summarized as the number and percentage of 
patients in each category. 
This is a single center pilot proof of concept study aiming to evaluate the safety, efficacy, and tolerability of 
PAE for the treatment of signs and symptoms BPH. A small number of subjects will be recruited for this 
purpose (30 subjects). We estimate it will take approximately 3 years to recruit, treat, and 
complete follow up on 30 subjects. 
No large randomized studies using PAE to treat BPH have been done to date. The sample size has 
been chosen to evaluate PAE using a US population. The results of the study will provide critical preliminary 
data to later guide in powering a more statistically robust, and larger randomized controlled trial in the future. 
Sample size justification 
To detect a statistically significant reduction from baseline in IPSS at 12 weeks, a sample size of 30 patients 
is computed based on the following assumptions: 
•  85% power 
•  2-sided alpha of 0.05 
•  Mean reduction of 5 points 
•  SD of reduction of 8 points The sample size of 28 is rounded up to 30 patients to take account 
of approximately 15% of patients who drop-out of the study. 
Planned analysis of clinical endpoints 
Change in IPSS, QoL bother question, BPH impact index and Qmax will be assessed using a one- sample 
t-test. A log transformation may be applied if required to adjust for skewed data. In addition a non-parametric 
Wilcoxon test will also be performed.