Trial Outcomes & Findings for Prostate Embolization for Benign Prostatic Hyperplasia (NCT NCT01924988)

NCT ID: NCT01924988

Last Updated: 2019-12-10

Results Overview

Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Evaluated 1 week after procedure
• Results posted on: 2019-12-10

Participant Flow

Participant milestones

Measure	Prostatic Embolization This single-center, Phase I prospective, observational, non-comparative study of the safety and effectiveness of prostate artery embolization for symptomatic benign prostatic hyperplasia. The primary outcome was to determine the frequency of adverse events, focusing on procedure-related bladder and rectal complications as detected by cystoscopic and anoscopic assessment post-treatment. The secondary objectives were to measure the effectiveness in diminishing symptoms of lower urinary tract symptom (LUTS) from treatment. The inclusion criteria were as follows: Men presenting with benign prostatic hyperplasia with symptoms for at least 6 months. Additional criteria included moderate to severe obstructive urinary tract symptoms as defined as an International Prostate Symptom Score (IPSS) score of 12 or greater, and peak urinary flow (QMax) of less than 12 mL/s or acute urinary retention.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prostate Embolization for Benign Prostatic Hyperplasia

Baseline characteristics by cohort

Measure	Safety of Prostate Artery Embolization n=15 Participants This is a study focused on the safety of prostate artery embolization based primarily on cystoscopic evaluation after embolization.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	69.6 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	15 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	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Prostate Size	71.9 Grams n=5 Participants
International Prostate Symptom Score (IPSS) score	23.2 units on a scale n=5 Participants
International index of erectile function- 5 (IIEF-5) score	12.2 units on a scale n=5 Participants
Baseline Cystoscopy findings	15 Participants n=5 Participants
Maximum urinary flow	7.3 ml/sec n=5 Participants

PRIMARY outcome

Timeframe: Evaluated 1 week after procedure

Population: 1 patient failed to complete this follow-up.

Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.

Outcome measures

Measure	Prostate Artery Embolization n=14 Participants Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
Number of Participants With Bladder or Rectal Injury	0 Participants

PRIMARY outcome

Timeframe: 3 months after treatment

Population: 9 participants failed to complete this follow-up.

Bladder injury as detected by cystoscopy

Outcome measures

Measure	Prostate Artery Embolization n=6 Participants Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
Detection of Bladder Injury	0 Participants

PRIMARY outcome

Timeframe: 6 months after treatment

Bladder injury detected by cystoscopy

Outcome measures

Measure	Prostate Artery Embolization n=7 Participants Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
Detection of a Bladder Injury Patients evaluated	7 Participants
Detection of a Bladder Injury Number with bladder injury	0 Participants

PRIMARY outcome

Timeframe: 12 months after the procedure

Number of patients with a bladder injury detected by cystoscopic examination

Outcome measures

Measure	Prostate Artery Embolization n=2 Participants Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
Detection of a Bladder Injury by Cystoscopy Number evaluated	2 Participants
Detection of a Bladder Injury by Cystoscopy Number with bladder injury	0 Participants

SECONDARY outcome

Timeframe: 1week, 3 months, 6months, 12months

Population: Some participants did not complete follow-up

Measure Description: Validated patient reported questionnaire to assess the severity of lower urinary tract symptoms associated with benign prostatic enlargement. Severity of symptom scores range from 0 to 35, with a score of 0-7 considered mild, 8-19 moderate and 20 to 35 severe symptoms.

Outcome measures

Measure	Prostate Artery Embolization n=14 Participants Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
International Prostate Symptom Score (IPSS) 1 week	15.2 score on a scale Interval 3.0 to 29.0
International Prostate Symptom Score (IPSS) 3 months	9.1 score on a scale Interval 2.0 to 21.0
International Prostate Symptom Score (IPSS) 6 months	9.5 score on a scale Interval 3.0 to 22.0
International Prostate Symptom Score (IPSS) 12 months	17.5 score on a scale Interval 17.0 to 18.0

SECONDARY outcome

Timeframe: 1week, 3 months, 6months, 12months

Population: Some participants did not complete follow-up

Measure Description: IIEF-5 is a 5 question validated patient reported outcome measure or erectile dysfunction (ED), with a range of scores from 5 to 25, and ED was classified into five categories or erectile function based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

Outcome measures

Measure	Prostate Artery Embolization n=15 Participants Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
International Index of Erectile Function (IIEF)- 5 1 week	17.3 score on a scale Interval 9.0 to 25.0
International Index of Erectile Function (IIEF)- 5 3 months	12.4 score on a scale Interval 5.0 to 24.0
International Index of Erectile Function (IIEF)- 5 6 months	11.9 score on a scale Interval 5.0 to 23.0
International Index of Erectile Function (IIEF)- 5 12 months	8 score on a scale Interval 7.0 to 9.0

SECONDARY outcome

Timeframe: 1week, 3 months, 6months, 12months

Population: Some participants did not complete follow-up

Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec.

Outcome measures

Measure	Prostate Artery Embolization n=15 Participants Therapeutic embolization of the prostate arteries to treat benign prostatic hyperplasia.
QMax (Peak Urinary Flow) 1 week	10.4 milliliters per second Interval 0.0 to 21.0
QMax (Peak Urinary Flow) 3 months	18.1 milliliters per second Interval 6.8 to 37.8
QMax (Peak Urinary Flow) 6 months	10.4 milliliters per second Interval 2.0 to 12.1
QMax (Peak Urinary Flow) 12 months	2.2 milliliters per second Interval 2.2 to 2.2

Adverse Events

Adverse Events

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Adverse Events n=15 participants at risk Summary of adverse events
Renal and urinary disorders Dysuria or urethral pain	40.0% 6/15 • Number of events 6 • 1 year Society of Interventional Radiology Adverse Events Classification Class A Minor, no treatment Class B Minor, medical or nominal therapy Class C Major, re-admission for less than 48 hrs, ED visit, minor intervention Class D Major, re-admission for greater than 48 hrs, major intervention Class E Major, permanent patient injury Class F Major, patient death
Renal and urinary disorders Hematuria	6.7% 1/15 • Number of events 1 • 1 year Society of Interventional Radiology Adverse Events Classification Class A Minor, no treatment Class B Minor, medical or nominal therapy Class C Major, re-admission for less than 48 hrs, ED visit, minor intervention Class D Major, re-admission for greater than 48 hrs, major intervention Class E Major, permanent patient injury Class F Major, patient death
Renal and urinary disorders acute prostatitis	6.7% 1/15 • Number of events 1 • 1 year Society of Interventional Radiology Adverse Events Classification Class A Minor, no treatment Class B Minor, medical or nominal therapy Class C Major, re-admission for less than 48 hrs, ED visit, minor intervention Class D Major, re-admission for greater than 48 hrs, major intervention Class E Major, permanent patient injury Class F Major, patient death
Renal and urinary disorders Reported fever and chills	6.7% 1/15 • Number of events 1 • 1 year Society of Interventional Radiology Adverse Events Classification Class A Minor, no treatment Class B Minor, medical or nominal therapy Class C Major, re-admission for less than 48 hrs, ED visit, minor intervention Class D Major, re-admission for greater than 48 hrs, major intervention Class E Major, permanent patient injury Class F Major, patient death
Nervous system disorders Headache and confusion	6.7% 1/15 • Number of events 1 • 1 year Society of Interventional Radiology Adverse Events Classification Class A Minor, no treatment Class B Minor, medical or nominal therapy Class C Major, re-admission for less than 48 hrs, ED visit, minor intervention Class D Major, re-admission for greater than 48 hrs, major intervention Class E Major, permanent patient injury Class F Major, patient death

Additional Information

James B. Spies MD MPH

Georgetown University Medical Center

Phone: 202-444-3450

Email: spiesj@gunet.georgetown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place