Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
Prostate artery embolization, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Quality of Life
Brief summary
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
Interventions
PROCEDUREProstate Artery Embolization
Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
PROCEDURESham Prostate Artery Embolization
Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.
Sponsors
Society of Interventional Radiology Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and those recording response will be blinded to cohort allocation.
Eligibility
Sex/Gender
MALE
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused. * International Prostate Symptom Score (I-PSS) score 14 or greater. * Quality of Life (QoL) score ≥ 3 * Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume \>125mL. * Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT. * Personal risk \<40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months. * Able to provide written consent. * Not participating in any other investigational drug or device studies.
Exclusion criteria
* • History of biopsy-proven prostate cancer * Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis) * Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia * Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia. * Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH * Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression. * Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery * Patients with platelet count \<50,000/μL or International Normalized Ratio (INR) \>1.8, unless corrected for the procedure * Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure. * Allergy to iodinated contrast agents unless pre-treated by corticosteroids. * Acute urinary retention. * Post void residual (PVR) \> 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR \>250 but urodynamic testing consistent with obstruction will be allowed. * Bladder stone within three months prior to the procedure. * Hematuria not evaluated by Urologist for causes other than BPH. * Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease. * Prior pelvic irradiation or radical pelvic surgery. Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score | 6 months | A survey accessing patient symptomology from BPH induced LUTS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 1, 3, 6, 9, 12, 24, 36 months | A survey accessing quality of life impact on patients from BPH induced LUTS. |
| Maximal urinary flow rate change from baseline | 6, 12, 24, and 36 months | Maximal flow rate of urine stream |
| Post void residual change from baseline | 6, 12, 24, and 36 months | Post void residual measures the volume of urine remaining in the bladder after complete emptying. |
| International Index of Erectile Function questionnaire (IIEF) | 1, 3, 6, 9, 12, 24, 36 months | A questionnaire designed to asses erectile function |
| Freedom from secondary intervention to treat BPH | 1, 3, 6, 9, 12, 24, 36 months | Recording of other surgical/procedural treatments with each procedure being recorded as an event. |
| International Prostate Symptom Score | 1, 3, 6, 9, 12, 24, 36 months | A survey accessing patient symptomology from BPH induced LUTS |
| Urinary Continence | 1, 6, and 12 months | Urinary Continence will be assessed using a 2 item questionnaire |
| Number of hospital days | 1 month | Number of hospital days following the procedure will be recorded |
| Recover experience | 1 month | Recover experience will be assessed using a quality of recovery visual analog scale |
| Adverse events | 7 days and 1, 3, 6, 9, 12, 24, 36 months | All procedure related adverse events will be recoreded |
| Ejaculatory function | 3, 6, 9, 12, 24, 36 months | Ejaculatory function will be assessed utilizing a four item questionnaire. |
Contacts
Primary ContactPooja Doshi
Outcome results
None listed