Benign Prostatic HyperplasiaNCT02930889
Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
A study testing Prostate Artery Embolization in people with Benign Prostatic Hyperplasia, run by University of Minnesota at 1 site in United States.
Trial summary
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Prostate Artery Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
Read the detailed description
This is a investigator-initiated evaluation of the safety and efficacy of treating benign prostatic hyperplasia (BPH) by prostatic artery embolization.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Prostate Artery Embolization
- Keywords
- Therapeutic Embolization, Prostatic Artery Embolization
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Artery EmbolizationDevice
Also called PAE
Prostate Artery Embolization
| Study group | Role | What they receive |
|---|---|---|
| Prostate Artery Embolization | Experimental | 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. Receives: Device: Prostate Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
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.
Measured: baseline, 3 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.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jafar Golzarian, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930889
- Sponsor's protocol ID
- RAD-2016-24154
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2016
- Last updated
- 2 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT02930889
- Acronym / sponsor ID
- RAD-2016-24154
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Therapeutic Embolization, Prostatic Artery Embolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Posted 15 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Artery Embolization | Experimental | Device: Prostate Artery EmbolizationProstate 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate Artery EmbolizationAlso: PAEProstate Artery Embolization | Device | Prostate Artery Embolization |
Primary outcome
Number of Adverse Events Reported
Time frame: 3 Months
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
Time frame: baseline, 3 months
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)
Time frame: 3 months
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
Time frame: 3 months
Participants will report change in medication use for prostate symptoms. The number of participants who reduce medications will be reported.
1 secondary outcome
Efficacy Measured by Medical Therapy of Prostatic Symptoms Questionnaire or Flow Rate Change
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jafar Golzarian, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate Artery Embolization in people with Benign Prostatic Hyperplasia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events Reported (time frame: 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.