Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930889
• Other study ID #: RAD-2016-24154
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.

Description:

This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

Inclusion Criteria:

• Male, 45 years or older
• Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia refractory to medical therapy for at least 6 months.
• IPSS score at initial evaluation should be greater than 12, and uroflowmetry (Qmax) of <15mL/s (milliliters per second).
• All prostate volumes will be > 40gm
• PSA which meets 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;Negative prostate biopsy (minimum 12 cores within 12 months) if abnormal digital rectal examination.

Exclusion Criteria:

• Patients with active urinary tract infections or recurrent urinary tract infections (> 2/year), prostatitis, or interstitial cystitis.
• Cases of biopsy proven prostate, bladder, or urethral cancer.
• Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy who are unwilling to stop therapy for 2 months prior to the study.
• Use of anithistamines, anti-convulsants, and antispasmodics within one week of treatment unless they have been treated with the same drug (at the same dosage) for at least 6 months and has an associated stable voiding pattern.
• Patients who are classified as New York Heart Association Class III (Moderate), or higher, have cardiac arrhythmias, have uncontrolled diabetes, or are known to be immunosuppressed.
• Hypersensitivity reactions to contrast material not manageable with prophylaxis.
• Patients with glomerular filtration rates less than 40 who are not already on dialysis
• Prostate volume <40 mL
• Patients with bilateral internal iliac arterial occlusion
• Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc)
• Patients with neurogenic or bladder atonia
• Prior prostatectomy
• Cystolithiasis within the last 3 months
• Patients interested in future fertility
• Patients with a life expectancy less than 1 year
• Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue
• Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg Parkinson's disease, multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).
• Patients with urethral stents
• Patients who have undergone prior rectal surgery other than hemorrhoidectomy or pelvic irradiation.
• Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to PAE

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Prostate Artery Embolization
Prostate Artery Embolization

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events Reported	All adverse events will be collected and reviewed. Adverse events are collected by self-report and medical record. Outcome is reported as the total number of adverse events reported.	3 Months
Primary	Change in International Prostate Symptom Score	The International Prostate Symptom Score assesses the severity of symptoms in benign prostatic hypertrophy. The questionnaire contains seven items rated on a scale from zero to five. Total scores are a sum of items scores and range from 0 to 35 with higher scores indicating worse BPH symptoms. Outcome is reported as the change in IPS score from baseline to three months.	baseline, 3 months
Primary	Change in Quality of Life Scale (QOLS)	Participants will complete the Quality of Life Scale (QOLS), which contains 15 items measuring five domains of quality of life. Total scores are a sum of item scores and range from 16 to 112, with higher scores indicating a better quality of life.	3 months
Primary	Patient Reported Change in Medication Use	Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported.	3 months
Secondary	Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change	The Medical Therapy of Prostatic Symptoms (MTOPS) Outcome is reported as the number of participants who experience treatment efficacy as defined by an MTOPS composite variable symptom score greater than 30 and/or flow rate change of 15 millimeters per second or greater.	3 months