Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres

Completed · Not applicable

Conditions studied: Benign Prostatic Hyperplasia (BPH)

In brief

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).

Key facts

Study ID

NCT03052049

Run by

Northwestern University

People needed

28

Starts

2017-09-06

Expected to finish

2022-09-26

Last updated by the study team

2023-10-10

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment. Patients with indwelling foley catheters will be treated with culture directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic testing and cystoscopy can be completed as part of the screening visit. It will be replaced when testing is completed.
• 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 ≥ 18 and IPSS bother score ≥ 3
• Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
• For men 45-59 years old: Prostate Specific Antigen) PSA < 2.5 (or) PSA 2.5-20 with a documented negative biopsy within previous 12 months.
• For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous 12 months.

You may not qualify if…

• 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 if criteria are met at the 1 year follow up 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 if criteria are met at the 1 year follow up 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 if criteria are met at the 1 year follow up 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 or if criteria are met at the 1 year follow up visit
• Daily use of a pad or device for incontinence required.
• Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures which have been treated successfully > 6 months prior are eligible)
• 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. VWD)
• 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), Photoselective Vaporization of the Prostate (PVP)
• Prior treatment for overactive bladder (e.g. intravesical botox)
• 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

Where it is running

• Northwestern — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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