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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate Artery Embolization
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Therapeutic Embolization, Prostatic Artery Embolization

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate Artery Embolization

Arm Description

Prostate Artery Embolization is a surgical procedure to relieve symptoms of Benign Prostatic Hyperplasia (BPH). Embolizing particles are injected into a target blood vessel to occlude blood flow.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 10, 2016
Last Updated
November 29, 2021
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02930889
Brief Title
Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Official Title
Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Therapeutic Embolization, Prostatic Artery Embolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate Artery Embolization
Arm Type
Experimental
Arm Description
Prostate Artery Embolization is a surgical procedure to relieve symptoms of Benign Prostatic Hyperplasia (BPH). Embolizing particles are injected into a target blood vessel to occlude blood flow.
Intervention Type
Device
Intervention Name(s)
Prostate Artery Embolization
Other Intervention Name(s)
PAE
Intervention Description
Prostate Artery Embolization
Primary Outcome Measure Information:
Title
Number of Adverse Events Reported
Description
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.
Time Frame
3 Months
Title
Change in International Prostate Symptom Score
Description
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.
Time Frame
baseline, 3 months
Title
Change in Quality of Life Scale (QOLS)
Description
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.
Time Frame
3 months
Title
Patient Reported Change in Medication Use
Description
Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jafar Golzarian, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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