- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02026908
Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)
Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment.
- Ability to understand and the willingness to sign a written informed consent
- Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months
- Men ≥ 45 years of age
- IPSS symptom score > 13 and IPSS bother score > 2
- Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
Exclusion Criteria:
- History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,
- On alpha-blockers within the past 2 weeks unless on a stable dose of medication, with a stable urination pattern for 2 weeks prior to enrollment, and the willingness to stay on the same dose for the duration of the study, or until stopping criteria is met at the 12 month f/u visit, and or/part of a trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR)
- On 5-alpha reductase inhibitors within the past 6 months unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping criteria is met at the 12 month f/u visit .
- On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping criteria is met at the 12 month f/u visit .
- On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study.
- Daily use of a pad or device for incontinence required.
- Urethral strictures, renal insufficiency (i.e. creatinine > 1.8)
- Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
- Neurogenic bladder, Hypotonic Bladder
- Prior treatment for urinary incontinence
- Penile prosthesis.
- Artificial urinary sphincter.
- Documented bacterial prostatitis within the past year.
- Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization.
- History of chronic prostatitis within the last 1 year
- Known bleeding disorders (e.g. von willebrand disease (VWD))
- History of urethral strictures/bladder neck closure (BNC)
- Prior prostate procedures (e.g. Transurethral microwave therapy (TUMT), transurethral needle ablation of the prostate (TUNA), water-induced thermotherapy (WIT), transurethral resection of the prostate (TURP), photo-vaporization of the prostate (PVP))
- Prior treatment for overactive bladder (e.g. intravesical botox)
- Prostate Specific Antigen (PSA) > 4.0, < 10.0 unless documented negative prostate biopsy within past 2 years and is not thought to harbor prostatic malignancy in the clinical opinion of the primary or co-investigator.
- Enrolled in another treatment trial for any disease within the past 30 days
- Declines or unable to provide informed consent
- Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease)
- Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac disease including congestive heart failure, significant respiratory disease, or known immunosuppression.
- A history of rectal malignancy
- Prior surgical prostate intervention
- Interest in future fertility
- Allergy to Iodinated contrast agents not responsive to steroid premedication regimen
- Contraindication to Conscious sedation
Study Plan
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 |
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Experimental: Prostate Artery Embolization
There is only one arm of this study where patients receive Prostate Artery Embolization
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Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
Time Frame: 5 years
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The number and the severity of adverse events will be recorded to evaluate safety. Events will be reported by subjects and the severity of events will be graded using the following scale: Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death |
5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in International Prostate Symptom Score (IPSS)
Time Frame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Questionnaire-IPSS has 7 questions. Answer choices are as follows. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. Scores can range from 0-35 with 0 being the better outcome and 35 the worst outcome. Question 1-6 0-Not at all
Question 7 0-None 1-1 time 2-2 times 3-3 times 4-4 times 5-5 or more times |
baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Change in Quality of Life (QOL) Bother Question
Time Frame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Questionnaire The total score ranges from 0-6 with 0 being the best outcome and 6 being the worst outcome. Questionnaire- answers choices are as follows: 0- Delighted
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baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index
Time Frame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Questionnaire The BPH Impact Index is to assess the impact of BPH symptoms on patient health and functioning. It is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.The BII is an evaluative index useful in measuring the magnitude of change in the impact of BPH-LUTS within a person over time. Scores range from 0-13 with 0 being the best outcome and 13 being the worst. Questionnaire- consists of 4 questions; answer choices are as follows Question 1: 0-none, 1-only a little, 2-some, 3-a lot Question 2: 0-none, 1-only a little, 2-some, 3-a lot Question 3: 0-not at all bothersome, 1- bothers me a little, 2-bothers me some, 3-bothers me a lot Question 4: 0-none of the time, 1- a little of the time, 2- some of the time, 3-most of the time, 4-all of the time |
baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
Time Frame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Measure of urine flow rate.
Q max = max flow rate.
Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements
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baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Riad Salem, MD MBA, Northwestern University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 00081296
- IDE G130133 (Other Identifier: FDA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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