Benign Prostatic Hyperplasia
Conditions
Keywords
Therapeutic Embolization, Prostatic Artery Embolization
Brief summary
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
Detailed description
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
Interventions
Prostate Artery Embolization
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: * Male, 45 years or older * Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months. * IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of \<15mL/s (milliliters per second). * All prostate volumes will be \> 40gm * PSA which meets one of the following criteria:Baseline PSA ≤ 2.5ng/mL, Baseline PSA \> 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required);Baseline PSA \> 2.5 ng/mL and ≤ 10 ng/mL AND free PSA \< 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Baseline PSA \>10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination.
Exclusion criteria
* Patients with active urinary tract infections or recurrent urinary tract infections (\> 2/year), prostatitis, or interstitial cystitis. * Cases of biopsy proven prostate, bladder, or urethral cancer. * Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study. * Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern. * Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed. * Hypersensitivity reactions to contrast material not manageable with prophylaxis. * Patients with glomerular filtration rates less than 40 who are not already on dialysis * Prostate volume \<40 mL * Patients with bilateral internal iliac arterial occlusion * Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc) * Patients with neurogenic or bladder atonia * Prior prostatectomy * Cystolithiasis within the last 3 months * Patients interested in future fertility * Patients with a life expectancy less than 1 year * Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue * Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg Parkinson's disease, multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.). * Patients with urethral stents * Patients who have undergone prior rectal surgery other than hemorrhoidectomy or pelvic irradiation. * Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to PAE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Reported | 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. |
| Change in International Prostate Symptom Score | 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. |
| Change in Quality of Life Scale (QOLS) | 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. |
| Patient Reported Change in Medication Use | 3 months | Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prostate Artery Embolization Prostate Artery Embolization
Prostate Artery Embolization: Prostate Artery Embolization | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion/exclusion criteria | 8 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Prostate Artery Embolization |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 67.2 years STANDARD_DEVIATION 9.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization | Change in International Prostate Symptom Score | -15.40 score on a scale | Standard Deviation 4.98 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Embolization | Change in Quality of Life Scale (QOLS) | -2.80 score on a scale | Standard Deviation 1.3 |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prostate Artery Embolization | Number of Adverse Events Reported | 7 adverse events |
Primary
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
Population: Measure was only collected from 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Artery Embolization | Patient Reported Change in Medication Use | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Artery Embolization | Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change | 0 Participants |