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

NCT02930889 | Completed Results DMC

• 1 other identifier: RAD-2016-24154
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia

Keywords

Therapeutic Embolization; Prostatic Artery Embolization

Outcome Measures

Primary Outcomes (4)

• Number of Adverse Events Reported

  All adverse events will be collected and reviewed. Adverse events are collected by self-report and medical record. Outcome is reported as the total number of adverse events reported.

  3 Months

• Change in International Prostate Symptom Score

  The International Prostate Symptom Score assesses the severity of symptoms in benign prostatic hypertrophy. The questionnaire contains seven items rated on a scale from zero to five. Total scores are a sum of items scores and range from 0 to 35 with higher scores indicating worse BPH symptoms. Outcome is reported as the change in IPS score from baseline to three months.

  baseline, 3 months

• Change in Quality of Life Scale (QOLS)

  Participants will complete the Quality of Life Scale (QOLS), which contains 15 items measuring five domains of quality of life. Total scores are a sum of item scores and range from 16 to 112, with higher scores indicating a better quality of life.

  3 months

• Patient Reported Change in Medication Use

  Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported.

  3 months

Secondary Outcomes (1)

• Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change

  3 months

Study Arms (1)

Prostate Artery Embolization

EXPERIMENTAL

Prostate Artery Embolization is a surgical procedure to relieve symptoms of Benign Prostatic Hyperplasia (BPH). Embolizing particles are injected into a target blood vessel to occlude blood flow.

Device: Prostate Artery Embolization

Interventions

Prostate Artery Embolization DEVICE

Prostate Artery Embolization

Also known as: PAE

Prostate Artery Embolization

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Jafar Golzarian, MD
• Organization: University of Minnesota

jafar@umn.edu

612-626-5566

Study Officials

• Jafar Golzarian, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: December 2, 2021
• Results First Posted: November 15, 2021

Record last verified: 2021-10

Locations

US (1)