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

NCT ID: NCT02930889

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2020-10-31

Brief Summary

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

Detailed Description

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate Artery Embolization

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.

Group Type: EXPERIMENTAL

Prostate Artery Embolization

Intervention Type: DEVICE

Prostate Artery Embolization

Interventions

Prostate Artery Embolization

Prostate Artery Embolization

Intervention Type: DEVICE

Other Intervention Names

PAE

Eligibility 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jafar Golzarian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RAD-2016-24154

Identifier Type: -

Identifier Source: org_study_id