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Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

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ClinicalTrials.gov Identifier: NCT02930889
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Prostate Artery Embolization Not Applicable

Detailed Description:
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Study Start Date : October 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prostate Artery Embolization
Prostate Artery Embolization
Device: Prostate Artery Embolization
Prostate Artery Embolization
Other Name: PAE




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 Months ]
    All adverse events will be collected and reviewed


Secondary Outcome Measures :
  1. International prostate symptom score [ Time Frame: 3 months ]
    Subject will complete a questionnaire regarding symptoms Scale of 1-5 regarding symptoms

  2. Quality of Life [ Time Frame: 3 months ]
    Quality of Life questionnaire will be administered at 3 month visit

  3. Post void Residual [ Time Frame: 3 months ]
  4. Peak Urinary Flow Rate [ Time Frame: 3 months ]
  5. Prostate Specific Antigen [ Time Frame: 3 months ]
    he post-void residual (PVR) urine test measures the amount of urine left in the bladder after urination.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria:

  • Male, 45 years or older
  • Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months.
  • IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of <15mL/s (milliliters per second).
  • All prostate volumes will be > 40gm
  • PSA which meets one of the following criteria:Baseline PSA ≤ 2.5ng/mL, Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required);Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination.

Exclusion Criteria:

  • Patients with active urinary tract infections or recurrent urinary tract infections (> 2/year), prostatitis, or interstitial cystitis.
  • Cases of biopsy proven prostate, bladder, or urethral cancer.
  • Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study.
  • Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern.
  • Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed.
  • Hypersensitivity reactions to contrast material not manageable with prophylaxis.
  • Patients with glomerular filtration rates less than 40 who are not already on dialysis
  • Prostate volume <40 mL
  • Patients with bilateral internal iliac arterial occlusion
  • Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc)
  • Patients with neurogenic or bladder atonia
  • Prior prostatectomy
  • Cystolithiasis within the last 3 months
  • Patients interested in future fertility
  • Patients with a life expectancy less than 1 year
  • Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue
  • Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg Parkinson's disease, multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).
  • Patients with urethral stents
  • Patients who have undergone prior rectal surgery other than hemorrhoidectomy or pelvic irradiation.
  • Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to PAE

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930889


Contacts
Contact: Shamar J Young, MD 612-626-5388 youn1862@umn.edu
Contact: Jafar Golzarian, MD 612-626-5388 jafar@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Shamar J Young, MD    612-626-5388    youn1862@umn.edu   
Contact: Jafar Golzarian, MD    612-626-5388    jafar@umn.edu   
Principal Investigator: Jafar Golzarian, MD         
Sub-Investigator: Shamar Young, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jafar Golzarian, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02930889     History of Changes
Other Study ID Numbers: G16004/A002
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Therapeutic Embolization
Prostatic Artery Embolization

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms