This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Prostate Artery Embolization
University of Minnesota
Minneapolis, Minnesota, United States
Number of Adverse Events Reported
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.
Time frame: 3 Months
Change in International Prostate Symptom Score
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.
Time frame: baseline, 3 months
Change in Quality of Life Scale (QOLS)
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.
Time frame: 3 months
Patient Reported Change in Medication Use
Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported.
Time frame: 3 months
Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change
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.
Time frame: 3 months
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