Recruiting

Prostate Artery Embolization

Sponsor:

University of Mississippi Medical Center

Code:

NCT04766268

Conditions

Benign Prostatic Hyperplasia (BPH)

Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Accepted

Interventions

Prostate artery embolization

Study Details

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

Study ID

NCT04766268

Start date

Mar 17, 2021

Status verified date

Feb, 2021

Completion date

Apr 10, 2023

Anticipated

Primary completion date

Feb 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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. 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.

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 ]
  • Change in quality of life assessment from baseline [ Time Frame: 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 ]
  • Successful removal of foley catheter in patient [ Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year and 2 years ]

Central Contacts and Locations

Central contacts

Jay Vasani, MD

601-984-4084jvasani@umc.edu

Locations

University of Mississippi Medical center

Recruiting

Jackson, Mississippi, United States, 39211

Contacts

Jay

810-288-8871jay.vasani@outlook.com

More Information

Sponsor

University of Mississippi Medical Center

Last update posted

Feb 24, 2022

Last verified

Feb, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Mississippi Medical Center on 2022-02-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.