Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)
Verified June 2016 by Northwestern University
Information provided by (Responsible Party):
Riad Salem, Northwestern University
First received: December 19, 2013
Last updated: June 28, 2016
Last verified: June 2016
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).
Benign Prostatic Hyperplasia (BPH)
Device: Prostate Artery Embolization
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
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
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2018 (Final data collection date for primary outcome measure)
Experimental: Prostate Artery Embolization
There is only one arm of this study where patients receive Prostate Artery Embolization
Device: Prostate Artery Embolization
Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
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. 50 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 Embospheres 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, 12 months post procedure and then annually for up to 4 years.
|Ages Eligible for Study:
||45 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02026908
|Northwestern Memorial Hospital
|Chicago, Illinois, United States, 60611 |
|Contact: Riad Salem, MD MBA 312-695-6371 email@example.com |
|Contact: Jennifer Karp, RN BSN 312-926-5289 firstname.lastname@example.org |
|Principal Investigator: Riad Salem, MD |
|Sub-Investigator: Howard Chrisman, MD |
|Sub-Investigator: Albert Nemcek Jr, MD |
|Sub-Investigator: John Hairston, MD |
|Sub-Investigator: Richard Chen, DO |
||Riad Salem, MD MBA
||Riad Salem, Professor of Radiology, Medicine and Surgery Chief, Section of Vascular and Interventional Radiology Director, Interventional Oncology Vice-Chairman, Image-Guided Therapy Department of Radiology Northwestern University, Northwestern University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 19, 2013
||June 28, 2016
||United States: Food and Drug Administration
Keywords provided by Northwestern University:
Prostate Artery Embolization
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 29, 2016
Genital Diseases, Male