- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02930889
Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
November 29, 2021 updated by: University of Minnesota
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prostate Artery Embolization
Prostate Artery Embolization is a surgical procedure to relieve symptoms of Benign Prostatic Hyperplasia (BPH).
Embolizing particles are injected into a target blood vessel to occlude blood flow.
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Prostate Artery Embolization
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events Reported
Time Frame: 3 Months
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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.
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3 Months
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Change in International Prostate Symptom Score
Time Frame: baseline, 3 months
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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.
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baseline, 3 months
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Change in Quality of Life Scale (QOLS)
Time Frame: 3 months
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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.
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3 months
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Patient Reported Change in Medication Use
Time Frame: 3 months
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Participants will report change in medication use for prostate symptoms.
The number of participants who reduce medications will be reported.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jafar Golzarian, MD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
October 31, 2020
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
October 10, 2016
First Submitted That Met QC Criteria
October 11, 2016
First Posted (Estimate)
October 12, 2016
Study Record Updates
Last Update Posted (Actual)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 29, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAD-2016-24154
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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