Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams

NCT02167009 | Unknown DMC

• 1 other identifier: TGH0003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

ARTERY EMBOLIZATION; BPH

Outcome Measures

Primary Outcomes (1)

• Improvement of BPH symptoms as assessed by the IPSS at 12 months post PAE.

  Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events and findings on physical examination.

Study Arms (1)

Prostate Artery Embolization

EXPERIMENTAL

Embospheres microspheres

Device: Embosphere Microspheres

Interventions

Embosphere Microspheres DEVICE

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

Prostate Artery Embolization

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampa General Hospital: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Cliff Davis, MD

  Tampa General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Hughes, RN

CONTACT

PAE@tgh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: June 18, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

US (1)