N/A N=21 Treatment

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

Benign Prostatic Hyperplasia

Bottom Line

View on ClinicalTrials.gov: NCT02930889 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Nov 2021

Primary outcome: Primary: Number of Adverse Events Reported — 7 adverse events

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Prostate Artery Embolization (Device)
Age: Adult, Older Adult · 45+ yrs
Sex: Male
Sponsor: University of Minnesota
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events Reported	7	—
PRIMARY Change in International Prostate Symptom Score	-15.40	—
PRIMARY Change in Quality of Life Scale (QOLS)	-2.80	—
PRIMARY Patient Reported Change in Medication Use	1	—
SECONDARY Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change	—	—

Summary

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

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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02930889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.