Benign Prostatic Hyperplasia (BPH)NCT04766268
Prostate Artery Embolization: Single Center Experience
A study testing Prostate artery embolization in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Benign prostatic hyperplasia (BPH) is an enlarged prostate gland from smooth muscle and glandular hyperplasia seen in the aging population with a prevalence of upto 90% in patients in the ninth decade. Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms
- What is being tested?
- Prostate artery embolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Mississippi Medical center
Jackson, Mississippi, 39211
Jay, 810-288-8871, jay.vasani@outlook.com
About this study
Official title: Prostate Artery Embolizaton: Single Center Experience
Benign prostatic hyperplasia (BPH) is an enlarged prostate gland from smooth muscle and glandular hyperplasia seen in the aging population with a prevalence of upto 90% in patients in the ninth decade. Lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) are the most common presenting symptoms of BPH. Patients are initially evaluated with a complete history and physical exam to rule out other causes of LUTS and assess the severity of LUTS with scoring systems such as the American Urologic Association Symptom Index (AUASI) or the International Prostate Symptom Score (IPSS). Patients with mild or no symptoms are treated with watchful waiting. Surgical procedure such as transurethral resection of the prostate and minimally invasive procedures such as microwave ablation and prostate artery embolization are performed in patients with failed medical management or patients who are not able to tolerate the side effects of the medications. Prostate artery embolization is a safe minimally invasive procedure shown to improve IPSS and quality of life with none or potential risk of minor complications shown in short, intermediate, and long term follow up.
Read the 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
- Being tested
- Prostate artery embolization
- Keywords
- PAE, Prostate artery embolization, Prostatic artery embolization, BPH, Lower urinary tract symptoms
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate artery embolizationOther
Also called PAE
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.
| Study group | Role | What they receive |
|---|---|---|
| PAE group | Experimental | 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. Receives: Other: Prostate artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in international prostate symptom score from baseline
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.
Measured: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
Change in quality of life assessment from baseline
Improvement of QOL from baseline. Scores include 0 - Delighted, 1- Pleased, 2- Mostly satisfied, 3 - Mixed, 4- mostly dissatisfied, 5 - Unhappy and 6 - Terrible
Measured: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
Change in post-void residual volume from baseline
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.
Measured: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
Successful removal of foley catheter in patient
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.
Measured: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
Secondary outcomes (3)
Change in prostate volume
Reduction in prostate volume at 3 months measured by US or MRI
Measured: Baseline, 3 months
Change in international index of erectile function
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)
Measured: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years
Determine the need for medication use after PAE
To determine successful cessation of BPH medicines at 1month post PAE
Measured: 1 month, 3 months, 6 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start17 Mar 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion10 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Vasani, University of Mississippi Medical Center
- Investigators
- Jay Vasani, MD, Principal investigator, University of Mississippi Medical CenterChadwick Huckabay, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766268
- Sponsor's protocol ID
- 2020V0337
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Artery Embolizaton: Single Center Experience
- ClinicalTrials.gov ID
- NCT04766268
- Acronym / sponsor ID
- 2020V0337
- Keywords
- PAE, Prostate artery embolization, Prostatic artery embolization, BPH, Lower urinary tract symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Benign prostatic hyperplasia (BPH) is an enlarged prostate gland from smooth muscle and glandular hyperplasia seen in the aging population with a prevalence of upto 90% in patients in the ninth decade. Lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) are the most common presenting symptoms of BPH. Patients are initially evaluated with a complete history and physical exam to rule out other causes of LUTS and assess the severity of LUTS with scoring systems such as the American Urologic Association Symptom Index (AUASI) or the International Prostate Symptom Score (IPSS). Patients with mild or no symptoms are treated with watchful waiting. Surgical procedure such as transurethral resection of the prostate and minimally invasive procedures such as microwave ablation and prostate artery embolization are performed in patients with failed medical management or patients who are not able to tolerate the side effects of the medications. Prostate artery embolization is a safe minimally invasive procedure shown to improve IPSS and quality of life with none or potential risk of minor complications shown in short, intermediate, and long term follow up.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm
| Arm | Type | Receives |
|---|---|---|
| PAE group | Experimental | Other: Prostate artery embolizationPatients 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate artery embolizationAlso: PAEProstate 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 | PAE group |
Primary outcome
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.
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
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.
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.
3 secondary outcomes
Change in prostate volume
Time frame: Baseline, 3 months
Change in international index of erectile function
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Vasani, MD principal investigator
University of Mississippi Medical Center
Chadwick Huckabay, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate artery embolization in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jay Vasani, MD (601-984-4084, jvasani@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in international prostate symptom score from baseline (time frame: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.