Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prospective, Non-Randomized, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia in Prostate Glands Larger Than 80 Grams

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05155891
• Other study ID #: 20210029
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 82
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Patient is age 50 or older.

2. Patient has signed informed consent and agrees to attend all follow-up study visits.

3. Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.

4. Patient has a baseline IPSS Score > 13 at baseline.

5. Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).

6. Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated, or refused.

7. Patient must be a candidate for HoLEP or PAE.

Exclusion Criteria:

1. Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)

2. Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).

3. Patients with indwelling urinary catheters or those performing self-catheterization.

4. Biopsy proven prostate or bladder cancer.

• Patient with elevated PSA will be counselled by urologist and a shared decision will be made with the patient after discussion about pros and cons of prostate biopsy.

5. Patients with neurogenic bladder disorder.

6. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition.

7. Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months).

8. Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.

9. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months.

10. Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent.

11. Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm

12. History of coagulation cascade disorders (which are not normalized by medical treatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.

13. History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm.

14. History of hypersensitivity to gelatin products will be excluded from PAE arm.

15. Subject has a life expectancy of less than 2 yrs.

16. Post void residual more than 500 ml at baseline.

17. Participation in any other BPH trials during the time of study.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Embosphere Microspheres
The SOC PAE procedure will be performed by attempting to embolize prostatic arteries of both sides in a single session with 300-500 um Embosphere Microspheres. The microspheres will be mixed with a contrast agent and will be delivered to the arteries supplying the prostate via a microcatheter.

Procedure:
• HoLEP Procedure
The SOC PAE procedure will be performed with the SOC HoLEP as per standard institutional guidelines. The HoLEP procedure involves passing a telescope through the urethra and removing the central part of the prostate gland using a laser.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BPH symptoms as measured by the IPSS	The International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms	Baseline, 3 months
Secondary	Duration of hospitalization after the procedure	The duration of hospitalization associated with each procedure will be calculated in hours.	up to 48 hours
Secondary	Duration of urinary catheterization after the procedure	The duration of urinary catheterization associated with each procedure will be calculated in hours.	up to 48 hours
Secondary	Change in BPH symptoms as measured by IPSS	International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms	Baseline, 12 months
Secondary	Change in peak urine flow rate	The peak urine flow rate (Qmax) will be measured via uroflowmetry	Baseline, 12 months
Secondary	Change in post-void residual urinary volume (PVR)	PVR will be measured using an ultrasound bladder scanner	Baseline, 12 months
Secondary	Change in erectile function as measured by the IIEF	The International Index of Erectile Function (IIEF) has a total score ranging from 0-25 with higher score indicating better erectile function	Baseline, 12 Months
Secondary	Change in retrograde ejaculation as measured by the Ejaculatory questionnaire	The Ejaculatory Questionnaire has a total score ranging from 0-20 with the higher score indicating better outcomes	Baseline, 12 Months
Secondary	Change in incontinence as measured by the ICIQ - UI SF	The International Consultation on Incontinence Questionnaire (ICIQ) -Urinary Incontinence (UI) Short Form (SF) is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.	Baseline, 12 Months
Secondary	Change in mean prostate volume	As measured by Magnetic Resonance Imaging (MRI) and transrectal ultrasound (TRUS)	Baseline, 12 months
Secondary	Change in prostate specific antigen (PSA) levels	As measured by serum blood samples	Baseline, 12 Months
Secondary	Incidence of adverse events	As evaluated by treating physician	Up to 12 Months
Secondary	Incidence of procedure-related adverse events	As evaluated by treating physician	Up to 12 Months
Secondary	Change in medication use related to BPH-LUTS	Change in BPH lower urinary tract symptoms (LUTS) medication use (including alpha blockers, 5-alpha reductase inhibitors and phosphodiesterase type 5 (PDE5) inhibitors) will be reported	Baseline, 12 Months