- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04766268
Prostate Artery Embolization: Single Center Experience
Prostate Artery Embolizaton: Single Center Experience
Study Overview
Status
Intervention / Treatment
Detailed Description
Benign prostatic hyperplasia (BPH) is an enlarged prostate from smooth muscle and glandular hyperplasia that results in lower urinary tract symptoms due to bladder outlet obstruction. It is seen in 8% of men in the fourth decade with increased prevalence to up to 90% of men in the ninth decade (1). Patients typically present with groups of symptoms referred to as lower urinary tract symptoms (LUTS) of which may include urgency, frequency, nocturia, incomplete bladder emptying, and weak urinary stream (2). LUTS is mainly categorized into irritative, obstructive, and mixed types. This has a variable impact on patients' quality of life by interfering with sleep, activities of daily living, anxiety, mobility, leisure, and effect on sexual activities (3). The risk factors for developing BPH include African American race, obesity, type 2 diabetes mellitus, high levels of alcohol consumption, and physical inactivity (4).
Patients with LUTs are evaluated with a complete history and physical to rule out causes other than BPH and bladder dysfunction such as excess fluid and caffeine intake, and use of medications including diuretics and antihistamine. Patients are further evaluated with screening tools such as the American Urologic Association Symptom Index (AUASI) or the International Prostate Symptom Score (IPSS) to determine the severity of LUTS secondary to BPH. IPSS is an 8 question screening tool that assesses the quality of life in addition to 7 questions in AUASI (4). Each question is scored from 0 to 5 and a minimum change of 3 points is considered a clinically important difference (5). Patients with AUASI score of less than 8 are considered to have mild or no symptoms and are managed with watchful waiting (6). Moderate or severe symptoms are considered in patients with AUASI score of 8 or greater than 8 and are managed with pharmacologic treatment including alpha-adrenergic receptor blockers, 5 alpha-reductase inhibitors, antimuscarinic agents, and phosphodiesterase 5 inhibitors. Additionally, international index of erectile function (IIEF) is used to further assess quality of life. For patients who have failed medical management, experience side effects from medications, or not interested in medical therapy are offered minimally invasive surgical treatment such as microwave ablation, surgical treatment including open prostatectomy and transurethral resection of the prostate (TURP) and interventional radiology procedure, prostate artery embolization.
Prostate artery embolization (PAE) is a safe and effective minimally invasive interventional radiology procedure in which intraprostatic vessels are embolized to shrink the size of the prostate gland. Preprocedural assessment includes IPSS, the international index of erectile function (IIEF-5) to asses pre-existing erectile dysfunction (7), postvoid residual (PVR) to objectively assess the degree of bladder outlet obstruction, cross-sectional imaging of the prostate gland, and screening for prostate cancer (8). The current indication for PAE is patients with moderate or severe LUTS from BPH who have not responded to medications or find medication side effects to be intolerable. Patients are excluded from the procedure in other causes of LUTS such as prostate cancer, neurogenic bladder prostatitis, urethral strictures. Clinical trials are underway that demonstrate the efficacy of the procedure and define indications and contraindications. Meta-analysis showed a statistically significant decrease in IPSS of 12.9, 15, 15, and 20.4 points from baseline at 1, 3, 6, 12 months, respectively (9). Additionally, statistically significant improvement in the quality of life and PVR were noted at 1, 3, 6, 12 months. An overall incidence of a compilation was 32.9% (9), the majority of which were classified as minor per SIR guidelines. Rectalgia, dysuria, and transient urinary retention were the most frequent minor complications of PAE. A few major complications related to PAE were severe urinary tract infection and bladder ischemia
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jay Vasani, MD
- Phone Number: 601-984-4084
- Email: jvasani@umc.edu
Study Locations
-
-
Mississippi
-
Jackson, Mississippi, United States, 39211
- Recruiting
- University of Mississippi Medical Center
-
Contact:
- Jay
- Phone Number: 810-288-8871
- Email: jay.vasani@outlook.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Anyone with international prostate symptom score greater than or equal to 8 (moderate to severe lower urinary tract symptoms)
- Quality of life assessment greater than 3
- Prostate volume greater than 40 cm3
- Men >45 years old
- Indwelling urinary catheter secondary to benign prostatic hyperplasia or moderate-severe lower urinary tract symptoms
Exclusion Criteria:
- Evidence of tortuous or severe atherosclerotic vessels on CT
- Neurogenic bladder
- <8 international prostate symptoms score
- Prostate volume less than 40cm3
- History of prostate cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PAE group
Patients with BPH with moderate lower urinary tract symptoms fulfilling the inclusion criteria and exclusion criteria will be enrolled in the trial to determine safety and effectiveness of prostate artery embolization and determine factors associated with improved procedure outcome.
|
Prostate artery embolization (PAE) is a safe and effective minimally invasive interventional radiology procedure in which intraprostatic vessels are embolized to shrink the size of the prostate gland.
LUTS is mainly categorized into irritative, obstructive, and mixed types.
This has a variable impact on patients' quality of life by interfering with sleep, activities of daily living, anxiety, mobility, leisure, and effect on sexual activities.
This trial aims to determine safety and effectiveness of prostate artery embolization and determine factors associated with improved procedure outcome.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in international prostate symptom score from baseline
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
IPSS is an assessment of patient's lower urinary tract symptoms which categorizes the symptoms into Mild (1-7), Moderate (8-19) Severe (20-35).
Decrease in the score means favorable outcome.
This score will measured during each follow up visit.
|
Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Change in quality of life assessment from baseline
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Improvement of QOL from baseline.
Scores include 0 - Delighted, 1- Pleased, 2- Mostly satisfied, 3 - Mixed, 4- mostly dissatisfied, 5 - Unhappy and 6 - Terrible
|
Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Change in post-void residual volume from baseline
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Improvement of PVR (Post void residue) compared to baseline.
This will be performed with either an US or automated bladder scanner demonstrating volume of urine remaining in the urinary bladder after urination.
|
Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Successful removal of foley catheter in patient
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
This outcome will be assessed for only those patients who are already wearing a foley catheter due to BPH related obstruction.
Number of these patients cannot be predetermined.
These patients will undergo the procedure while they are wearing the catheter.
Once the procedure is performed they will return to the clinic for voiding trial (assess if the foley can be removed).Success in removal of foley catheter after spontaneous voiding with PVR <200 ml.
Favorable outcome will be that the patient is able to void freely without needing a foley catheter.
|
Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in prostate volume
Time Frame: Baseline, 3 months
|
Reduction in prostate volume at 3 months measured by US or MRI
|
Baseline, 3 months
|
Change in international index of erectile function
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Change in IIEF/SHIM score compared to baseline.
This score is a measure of severity of erectile dysfunction where score of 22-25 (No ED), 17-21 (mild ED), 12-16 ( mild to moderate), 8-11 (moderate), 5-7 (Severe)
|
Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
|
Determine the need for medication use after PAE
Time Frame: 1 month, 3 months, 6 months, 1 year and 2 years
|
To determine successful cessation of BPH medicines at 1month post PAE
|
1 month, 3 months, 6 months, 1 year and 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jay Vasani, MD, University of Mississippi Medical Center
- Principal Investigator: Chadwick Huckabay, MD, University of Mississippi Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020V0337
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lower Urinary Tract Symptoms
-
The Royal College of Surgeons of EnglandUniversity College, LondonCompletedUncomplicated Lower Urinary Tract Symptoms
-
National Taiwan University HospitalUnknownDisorder of the Lower Urinary TractTaiwan
-
ProVerum MedicalNot yet recruitingBPH With Symptomatic Lower Urinary Tract Symptoms
-
Baylor Research InstituteForte MedicalCompletedLower Urinary Tract Symptoms | Lower Urinary Tract InfectionUnited States
-
The University of Texas Medical Branch, GalvestonCompletedLower Urinary Tract Symptoms | Lower Gastrointestinal Tract Symptoms
-
Far Eastern Memorial HospitalCompletedPsychiatric Aspects in Women With Lower Urinary Tract SymptomsTaiwan
-
Jagiellonian UniversityPiotr ChlostaCompletedTo Evaluate Lower Urinary Tract Symptoms (LUTS) in PolandPoland
-
San Carlo di Nancy HospitalLampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)CompletedBPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsItaly
-
Boston Scientific CorporationTerminatedBPH | BPH With Urinary Obstruction | BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsUnited States, Australia
-
Benaroya Research InstituteVirginia Mason Hospital/Medical CenterUnknownPain | BPH With Urinary Obstruction | BPH With Urinary Obstruction With Other Lower Urinary Tract SymptomsUnited States
Clinical Trials on Prostate artery embolization
-
Society of Interventional Radiology FoundationNot yet recruitingLower Urinary Tract Symptoms | Benign Prostatic Hyperplasia
-
Merit Medical Systems, Inc.CompletedLower Urinary Tract Symptoms | Benign Prostatic HyperplasiaUnited States, United Kingdom, Italy, France
-
Northwestern UniversityCompletedBenign Prostatic Hyperplasia (BPH)United States
-
IMBiotechnologies Ltd.CompletedBenign Prostatic Hyperplasia | Benign Prostatic HypertrophyCanada
-
Saskatchewan Health Authority - Regina AreaCompleted
-
Group of Research in Minimally Invasive TechniquesUniversidad de Zaragoza; Hospital Clínico Universitario Lozano BlesaWithdrawnBenign Prostatic HyperplasiaSpain
-
Shivank BhatiaMerit Medical Systems, Inc.; Society of Interventional Radiology FoundationTerminatedProstate CancerUnited States
-
University of MinnesotaCompletedBenign Prostatic HyperplasiaUnited States
-
University of California, San DiegoCompletedProstatic Hyperplasia, Benign | Enlarged Prostate With Lower Urinary Tract SymptomsUnited States
-
Germans Trias i Pujol HospitalUnknownBenign Prostatic HyperplasiaSpain