Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Riad Salem, Northwestern University
ClinicalTrials.gov Identifier:
NCT02026908
First received: December 19, 2013
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention
Benign Prostatic Hyperplasia (BPH)
Device: Prostate Artery Embolization

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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:
  • Change in International Prostate Symptom Score (IPSS) [ Time Frame: baseline, 4 weeks, 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
    Questionnaire

  • Change in quality of life (QOL) bother question [ Time Frame: baseline, 4 weeks, 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
    Questionnaire

  • Change in benign prostatic hyperplasia (BPH) impact index [ Time Frame: baseline, 4 weeks, 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
    Questionnaire

  • Change in Qmax (peak and total void volume at each follow‐up visit) [ Time Frame: baseline, 4 weeks, 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
    Measure of urine flow rate. Q max = max flow rate.


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 - 90 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 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.
  • On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks.
  • On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication and 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026908

Contacts
Contact: Jennifer Karp, RN 312-926-5289 jkarp@nmff.org

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Riad Salem, MD MBA    312-695-6371    r-salem@northwestern.edu   
Contact: Sherrie Wolfe, RN BSN    312-503-2308    s-wolfe@northwestern.edu   
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         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Riad Salem, MD MBA Northwestern University
  More Information

No publications provided

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02026908     History of Changes
Other Study ID Numbers: STU 00081296, IDE G130133
Study First Received: December 19, 2013
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Prostate Artery Embolization
PAE
Benign Prostatic Hyperplasia
BPH
Lower Urinary Tract Symptoms
LUTS

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014