Clinical trial NCT02026908: Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)
Official title: Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Prostate Artery Embolization
PAE
Benign Prostatic Hyperplasia
BPH
Lower Urinary Tract Symptoms
LUTS
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 45
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 5 years
Secondary outcomes:
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
measure: Change in Quality of Life (QOL) Bother Question
timeFrame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
measure: Change in Benign Prostatic Hyperplasia (BPH) Impact Index
timeFrame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
measure: Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
timeFrame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Riad Salem, MD MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salem R, Hairston J, Hohlastos E, Riaz A, Kallini J, Gabr A, Ali R, Jenkins K, Karp J, Desai K, Thornburg B, Casalino D, Miller F, Hofer M, Hamoui N, Mouli S. Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study. Urology. 2018 Oct;120:205-210. doi: 10.1016/j.urology.2018.07.012. Epub 2018 Jul 20.