Trial Outcomes & Findings for Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) (NCT NCT02930889)

NCT ID: NCT02930889

Last Updated: 2021-12-02

Results Overview

All adverse events will be collected and reviewed. Adverse events are collected by self-report and medical record. Outcome is reported as the total number of adverse events reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 Months
• Results posted on: 2021-12-02

Participant Flow

Participant milestones

Measure	Prostate Artery Embolization Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Overall Study STARTED	21
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Prostate Artery Embolization Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	6
Overall Study Did not meet inclusion/exclusion criteria	8

Baseline Characteristics

Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Baseline characteristics by cohort

Measure	Prostate Artery Embolization n=5 Participants Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	67.2 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 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	5 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	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

All adverse events will be collected and reviewed. Adverse events are collected by self-report and medical record. Outcome is reported as the total number of adverse events reported.

Outcome measures

Measure	Prostate Artery Embolization n=5 Participants Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Number of Adverse Events Reported	7 adverse events

PRIMARY outcome

Timeframe: baseline, 3 months

The International Prostate Symptom Score assesses the severity of symptoms in benign prostatic hypertrophy. The questionnaire contains seven items rated on a scale from zero to five. Total scores are a sum of items scores and range from 0 to 35 with higher scores indicating worse BPH symptoms. Outcome is reported as the change in IPS score from baseline to three months.

Outcome measures

Measure	Prostate Artery Embolization n=5 Participants Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Change in International Prostate Symptom Score	-15.40 score on a scale Standard Deviation 4.98

PRIMARY outcome

Timeframe: 3 months

Participants will complete the Quality of Life Scale (QOLS), which contains 15 items measuring five domains of quality of life. Total scores are a sum of item scores and range from 16 to 112, with higher scores indicating a better quality of life.

Outcome measures

Measure	Prostate Artery Embolization n=5 Participants Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Change in Quality of Life Scale (QOLS)	-2.80 score on a scale Standard Deviation 1.30

PRIMARY outcome

Timeframe: 3 months

Population: Measure was only collected from 2 participants.

Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported.

Outcome measures

Measure	Prostate Artery Embolization n=2 Participants Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Patient Reported Change in Medication Use	1 Participants

SECONDARY outcome

Timeframe: 3 months

The Medical Therapy of Prostatic Symptoms (MTOPS) Outcome is reported as the number of participants who experience treatment efficacy as defined by an MTOPS composite variable symptom score greater than 30 and/or flow rate change of 15 millimeters per second or greater.

Outcome measures

Measure	Prostate Artery Embolization n=5 Participants Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change	0 Participants

Adverse Events

Prostate Artery Embolization

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prostate Artery Embolization n=5 participants at risk Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	20.0% 1/5 • Number of events 1 • 12 months

Other adverse events

Measure	Prostate Artery Embolization n=5 participants at risk Prostate Artery Embolization Prostate Artery Embolization: Prostate Artery Embolization
Gastrointestinal disorders Loose Stool	20.0% 1/5 • Number of events 1 • 12 months
Renal and urinary disorders Burning Sensation While Urinating	20.0% 1/5 • Number of events 2 • 12 months
Reproductive system and breast disorders Post Procedure Penile Pain	20.0% 1/5 • Number of events 1 • 12 months
Renal and urinary disorders Blood in Urine	20.0% 1/5 • Number of events 1 • 12 months

Additional Information

Jafar Golzarian, MD

University of Minnesota

Phone: 612-626-5566

Email: jafar@umn.edu

Results disclosure agreements

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