- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03052049
Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres
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
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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. 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.
- 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 ≥ 18 and IPSS bother score ≥ 3
- Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
- 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.
- For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous 12 months.
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 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).
- 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
- 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.
- 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
- Daily use of a pad or device for incontinence required.
- Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures which have been treated successfully > 6 months prior are eligible)
- 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. VWD)
- 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)
- Prior treatment for overactive bladder (e.g. intravesical botox)
- 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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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .
Time Frame: 1 year
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The number of graded adverse events was recorded to evaluate safety. They were graded using the following scale at 1, 3, 6, and 12 months post procedure: 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. |
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in International Prostate Symptom Score (IPSS)
Time Frame: Baseline, 1, 3, 6, 12 months post procedure
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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, 1, 3, 6, 12 months post procedure
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Change in Quality of Life (QOL) Bother Score
Time Frame: Baseline, 1, 3, 6, 12 months post procedure
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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, 1, 3, 6, 12 months post procedure
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Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score
Time Frame: Baseline, 1, 3, 6, 12 months post procedure
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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, 1, 3, 6, 12 months post procedure
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Change in Peak Urine Flow (Qmax)
Time Frame: Baseline, 1, 3, 6, and 12 months post procedure
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Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements
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Baseline, 1, 3, 6, and 12 months post procedure
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Bartley Thornburg, MD, Northwestern University
- Study Chair: Kush Desai, MD, Northwestern University
- Study Chair: Ahsun Riaz, MD, Northwestern University
- Study Chair: Matthias Hofer, MD, Northwestern University
- Study Chair: Samdeep Mouli, MD, Northwestern University
- Principal Investigator: Riad Salem, MD, Northwestern University
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 (Actual)
Study Record Updates
Last Update Posted (Estimated)
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 00204385
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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