Recruiting

Observational Study

Sponsor:

Tampa General Hospital

Code:

NCT02167009

Conditions

Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Embosphere Microspheres

Study Details

Brief summary:

Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.

Conditions

Benign Prostatic Hyperplasia

Study ID

NCT02167009

Start date

Dec, 2014

Status verified date

Sep, 2019

Completion date

May, 2020

Anticipated

Primary completion date

May, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient is aged 50-85 years
  • Patient has signed informed consent
  • Patient has experienced lower urinary tract symptoms (LUTS) for at least 1 year prior to study enrollment
  • Patient has a prostate size larger than 90g as measured by transrectal ultrasound (TRUS)
  • Patient has an IPSS score greater than or equal to 13
  • Patient has a peak urine flow rate < 12 mL/sec
  • Patient either:
  • Refuses surgical treatment
  • Is considered high risk for surgical treatment
  • Patient is either:
  • Refractory to medical treatment
  • Contraindicated for medical treatment
  • Patient must meet ONE of the following criteria:
  • Baseline PSA ≤ 2.5ng/mL
  • Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required)
  • Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months
  • Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months

Exclusion Criteria:

  • History of prostate or bladder cancer, or currently being evaluated for cancer
  • History of prostate or bladder cancer, or currently being evaluated for cancer
  • Patient has taken alpha blockers within 4 weeks of screening
  • Patient has experienced an irregular voiding pattern despite medical management with a stable 5-alpha reductase inhibitor dosage for 3 months or longer
  • History of open prostate surgery, radiofrequency, or microwave therapy
  • Previous open bladder or rectosigmoid colon surgery
  • TURP within the last two years
  • Patient has nodularity or induration detected upon digital rectal examination (DRE)
  • Neurogenic bladder or other neurological disorder impacting bladder function
  • Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
  • Acute urinary retention requiring an indwelling catheter
  • Bladder atonia
  • Active prostatitis or urinary tract infection
  • Cystolithiasis within the past 3 months
  • Serum creatinine >1.7mg/dL
  • Coagulation disturbances not normalized by medical treatment
  • Iodinated contrast allergy not controlled with 24-hour steroid preparation
  • History of gelatin allergy
  • History of pelvic irradiation
  • History of severe peripheral vascular disease or known major iliac arterial occlusive disease
  • History of smoking greater than 30 pack-years
  • Interest in future fertility
  • Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure
  • Any other risks or factors that the Investigator believes puts the patient at risk for a complication during the procedure

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prostate Artery Embolization

Embospheres microspheres

Interventions

Embosphere Microspheres

Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

Primary outcome measure

  • Improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE. [ Time Frame: Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination. ]

Central Contacts and Locations

Central contacts

Michelle Hughes, RN

PAE@tgh.org

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

More Information

Sponsor

Tampa General Hospital

Last update posted

Sep 10, 2019

Last verified

Sep, 2019

Keywords

  • ARTERY EMBOLIZATION
  • BPH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tampa General Hospital on 2019-09-10.