Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres
Study Details
Study Description
Brief Summary
This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This pilot study will be a single center, open labeled, non-randomized feasibility study to evaluate the initial safety of PAE for the treatment of symptomatic bladder outlet obstruction. 30 adult male subjects will be enrolled in this study. If eligible patients will undergo the prostate artery embolization procedure in the Interventional Radiology department. An angiogram of the prostate arteries will be done. Small beads called Bead Block microspheres will be injected into the prostate artery to slow blood flow to the prostate in the hope of providing relief with minimal side effects and complications, for lower urinary tract symptoms caused by BPH. After the procedure the patient will be followed at 4 weeks, 12 weeks, 6 months, and 12 months post procedure.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prostate Artery Embolization There is only one arm of this study where patients receive Prostate Artery Embolization |
Device: Prostate Artery Embolization
The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [3 years]
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. Specific events evaluated will include Infection at procedure or urinary catheter site, prostate abscess, pain, hematospermia, hematuria, burning in the urethra, diarrhea, bleeding from the rectum, bladder injury, and radiation exposure by physical exam, lab value and urine flow testing at 1, 3, 6, and 12 months post procedure.
Secondary Outcome Measures
- Change in International Prostate Symptom Score (IPSS) [Baseline, 1, 3, 6, 12 months post procedure]
Questionnaire
- Change in quality of life (QOL) bother score [Baseline, 1, 3, 6, 12 months post procedure]
Questionnaire
- Change in benign prostatic hyperplasia (BPH) impact index score [Baseline, 1, 3, 6, 12 months post procedure]
Questionnaire
- Change in Qmax (peak and total void volume at each follow-up visit) [Baseline, 1, 3, and 12 months post procedure]
Measure of urine flow rate. Q max = max flow rate.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment. Patients with indwelling foley catheters will be treated with culture directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic testing and cystoscopy can be completed as part of the screening visit. It will be replaced when testing is completed.
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Ability to understand and the willingness to sign a written informed consent.
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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.
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Men ≥ 45 years of age
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IPSS symptom score ≥ 18 and IPSS bother score ≥ 3
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Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
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For men 45-59 years old: Prostate Specific Antigen) PSA < 2.5 (or) PSA 2.5-20 with a documented negative biopsy within previous 12 months.
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For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous 12 months.
Exclusion Criteria:
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History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,
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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 if criteria are met at the 1 year follow up visit and/or part of a Trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR).
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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 if criteria are met at the 1 year follow up visit
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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 if criteria are met at the 1 year follow up visit.
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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 or if criteria are met at the 1 year follow up visit
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Daily use of a pad or device for incontinence required.
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Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures which have been treated successfully > 6 months prior are eligible)
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renal insufficiency (i.e. creatinine > 1.8)
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Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
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Neurogenic bladder, Hypotonic Bladder
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Prior treatment for urinary incontinence
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Penile prosthesis.
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Artificial urinary sphincter.
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Documented bacterial prostatitis within the past year.
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Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization.
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History of chronic prostatitis within the last 1 year
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Known bleeding disorders (e.g. VWD)
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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), Photoselective Vaporization of the Prostate (PVP)
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Prior treatment for overactive bladder (e.g. intravesical botox)
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Enrolled in another treatment trial for any disease within the past 30 days
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Declines or unable to provide informed consent
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Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease)
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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.
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A history of rectal malignancy
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Prior surgical prostate intervention
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Interest in future fertility
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Allergy to iodinated contrast agents not responsive to steroid premedication regimen
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Contraindication to conscious sedation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- BTG International Inc.
Investigators
- Principal Investigator: Riad Salem, MD, Northwestern University
- Study Chair: John Hairston, MD, Northwestern University
- Study Chair: Bartley Thornburg, MD, Northwestern University
- Study Chair: Kush Desai, MD, Northwestern University
- Study Chair: Ahsun Riaz, MD, Northwestern University
- Study Chair: Matthias Hoffer, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU 00204385