Prostate Artery Embolization: Single Center Experience

NCT04766268 | Unknown

• 1 other identifier: 2020V0337
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms

Keywords

PAE; Prostate artery embolization; Prostatic artery embolization; BPH; Lower urinary tract symptoms

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  Baseline, 1 month, 3 months, 6 months, 1 year and 2 years

Secondary Outcomes (3)

• Change in prostate volume

  Baseline, 3 months

• Change in international index of erectile function

  Baseline, 1 month, 3 months, 6 months, 1 year and 2 years

• Determine the need for medication use after PAE

  1 month, 3 months, 6 months, 1 year and 2 years

Study Arms (1)

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.

Other: Prostate artery embolization

Interventions

Prostate artery embolization OTHER

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.

Also known as: PAE

PAE group

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical center

Jackson, Mississippi, 39211, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay Vasani, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

• Chadwick Huckabay, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Vasani, MD

CONTACT

601-984-4084; jvasani@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, single arm

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: February 23, 2021
• Study Start: March 17, 2021
• Primary Completion: February 1, 2023
• Study Completion: April 10, 2023
• Last Updated: February 24, 2022

Record last verified: 2021-02

Locations

US (1)