Benign Prostatic Hyperplasia
Conditions
Keywords
BPH, Prostate, Prostatic Hyperplasia, enlarged prostate, LUTS, urinary retention
Brief summary
The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).
Detailed description
The study will consist of a screening period in which patient eligibility will be determined and baseline assessments performed. Once eligibility is confirmed, patients will be enrolled within 4 weeks of baseline imaging to receive either TURP or PAE with Embosphere Microspheres. After treatment, patients will return for follow-up visits at Months 1, 3, 6, and 12. At each of these visits patients will complete IPSS and IIEF questionnaires and have a physical exam, laboratory assessments (including PSA), a DRE, and a transrectal ultrasound of the prostate. At each visit patients will have a cystoscopy and proctoscopy if medically indicated. Cystoscopy is necessary in all cases of hematuria (injury associated with bleeding). Proctoscopy is necessary in all cases of bleeding per the rectum. An MRI of the prostate will be conducted at the 3 and 12 month visits. Uroflowmetry testing will be performed at the 1 and 12 month visits, and at other visits if medically indicated. MRIs will be assessed by blinded Central Reviewers. The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post treatment. Patients will continue to be followed annually for up to 4 additional years. At a minimum, patients will be requested to complete the IPSS and International Index of Erectile Dysfunction (IIEF) questionnaires by telephone, email or mail once per year during this long term follow up period. Patients who are willing to return to the clinic will have a physical exam, MRI of the prostate, digital rectal exam (DRE), transrectal ultrasound of the prostate, PSA, and uroflowmetry testing performed each year. Treatments for LUTS due to BPH after the study treatment and 12 month follow up are complete will be documented during the long term follow up period to the extent possible. This long term follow up data will be summarized and submitted separately from the data for the initial 12 months of this study. Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events, as well as changes in laboratory values, and findings on physical examination. Concomitant medication usage will be assessed. A follow up ECG will be performed at the 12 month visit. Patient recruitment is anticipated to take approximately 2 years. Duration of each patient's participation is expected to be 5 years, including a 4 year long term follow up period. The total duration of the study will be approximately 7 years, including long term follow up.
Interventions
DEVICEEmbosphere Microspheres
PROCEDURETURP
Sponsors
Merit Medical Systems, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is age 50 to 79, inclusive 2. Patient has signed informed consent 3. Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment 4. Patient has a baseline IPSS Score \> 13 at baseline 5. Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI 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 TURP 8. Patient must meet one of the following criteria: * Baseline Prostate Specific Antigen (PSA) \<2.5 ng/mL (no prostate biopsy required) * Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA \> 25% of total PSA (no prostate biopsy required) * Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA \< 25% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy) * Baseline PSA \>10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)
Exclusion criteria
1. Active urinary tract infection 2. Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer * The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study: * Patients with digital rectal examination (DRE) findings suspicious for prostate cancer * Patients with baseline PSA levels \> 10 ng/mL * Patients with baseline PSA levels \>2.5 ng/mL and \< 10ng/mL AND free PSA \< 25% of total PSA * Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study 3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc) 4. 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 5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern • Dosage of these medications should not change during study participation unless medically necessary 6. Patient has taken antidepressants, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern 7. Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern 8. Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate 9. 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. 10. Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug (NSAID) or anti-platelet therapy for 7 days prior to study treatment 11. Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint, etc) 12. Patient has an asymmetric prostate, with \> 20% difference in size between lobes 13. 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 14. Baseline serum creatinine level \> 1.8 mg/dl 15. Known upper tract renal disease 16. Cystolithiasis or chronic hematuria within 3 months prior to study treatment 17. Active prostatitis 18. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease 19. History of pelvic irradiation or radical pelvic surgery 20. Patient is interested in future fertility 21. Coagulation disturbances not normalized by medical treatment 22. Acute urinary retention requiring an indwelling catheter 23. Known major iliac arterial occlusive disease 24. Allergy to iodinated contrast agents 25. Hypersensitivity to gelatin products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) - Total Score at 12 Months | 12 months | The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hospitalization Post Procedure | 1 month | The duration of hospitalization associated with the procedure will be calculated in hours. T |
| Duration of Post Procedure Catheterization | 1 month | The duration of post procedure catheterization will be calculated in hours. |
| Number of Adverse Events Per Patient | Through early termination of study (with less than 25% of subjects completing 12 month follow up) | Adverse events during the study were predominantly mild. There are over 4 times as many PAE patients as TURP, so the overall incidence rate of events is proportional to the size of the cohort represented. The most common events among patients who underwent embolization were transient dysuria, bladder spasm, hematuria, hematospermia, nausea and fever. The last 2 are typical of post embolic syndrome common to all embolization procedures. The most frequent adverse events for surgery patients were dysuria and hematuria. Events also include non-TEAEs. |
| Number of Patients With Procedure Related Adverse Events | TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up | Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the case report form (CRF) which began prior to treatment will not be included in the summary tables but will be included in the AE data listings. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Free Prostate Specific Antigen (PSA) at 6 Month Follow up | 6 month follow up | Free PSA percentage summarized for both groups at 6 months follow up |
| Total Prostate Specific Antigen (PSA) at 6 Months | 6 months | Prostate specific antigen (PSA) will be summarized for both treatment groups for 6 month time point |
| Peak Urine Flow Rate (Qmax) at 1 Month | 1 month follow-up | The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments was assessed at 1 month follow up. (Additional timepoints were not assessed due to early termination). |
| International Index of Erectile Function (IIEF) | 6 months | Erectile Function (Questions 1-5 & 15), score range 0-5, max score = 30 Orgasmic Function (Questions 9-10), score range 0-5, max score = 10 Sexual Desire (Questions 11-12), score range 1-5, max score = 10 Intercourse Satisfaction (Questions 6-8), score range 0-5, max score = 15 Overall Satisfaction (Questions 13-14), score range 1-5, max score = 10 SCORING for erectile dysfunction (Total of Q1-5 and Q15) is interpreted as follows: 1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction For all subscales, higher scores = less dysfunction/dissatisfaction Total IIEF is out of 75 |
| Mean Prostate Volume, as Determined by MRI | 3 month follow-up | The mean prostate volume as assessed by MRI is summarized at 3 month time point. |
| Post-void Residual Urinary Volume (PVR) | 1 month follow-up | The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments is summarized for both treatment groups at 1 month time point. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prostate Artery Emoblization (PAE) Prostate artery embolization using Embosphere Microspheres
Embosphere Microspheres | 52 |
| Transurethral Resection of the Prostate (TURP) Transurethral Resection of the Prostate (TURP)
TURP | 7 |
| Total | 59 |
Baseline characteristics
| Characteristic | Prostate Artery Emoblization (PAE) | Transurethral Resection of the Prostate (TURP) | Total |
|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 6.73 | 62.9 years STANDARD_DEVIATION 76.74 | 64.9 years STANDARD_DEVIATION 6.72 |
| Detrusor Pressure (Pdet) (mmH2O) | 88.3 mmH2O STANDARD_DEVIATION 71.25 | 80.9 mmH2O STANDARD_DEVIATION 38.69 | 87.4 mmH2O STANDARD_DEVIATION 67.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 2 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 5 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Free Prostate Specific Antigen (PSA) | 22.5 percentage of Free PSA STANDARD_DEVIATION 8.99 | 21.8 percentage of Free PSA STANDARD_DEVIATION 9.65 | 22.4 percentage of Free PSA STANDARD_DEVIATION 8.91 |
| International Index of Erectile Function (IIEF) - Total Erectile function sub-score | 11.7 units on a scale STANDARD_DEVIATION 9.82 | 20.1 units on a scale STANDARD_DEVIATION 10.99 | 12.7 units on a scale STANDARD_DEVIATION 10.25 |
| International Index of Erectile Function (IIEF) - Total Intercourse satisfaction sub-score | 4.1 units on a scale STANDARD_DEVIATION 4.63 | 8.0 units on a scale STANDARD_DEVIATION 6.08 | 4.5 units on a scale STANDARD_DEVIATION 4.93 |
| International Index of Erectile Function (IIEF) - Total Orgasmic function sub-score | 4.2 units on a scale STANDARD_DEVIATION 3.76 | 5.7 units on a scale STANDARD_DEVIATION 4.11 | 4.4 units on a scale STANDARD_DEVIATION 3.81 |
| International Index of Erectile Function (IIEF) - Total Overall satisfaction sub-score | 4.5 units on a scale STANDARD_DEVIATION 2.79 | 7.3 units on a scale STANDARD_DEVIATION 3.3 | 4.8 units on a scale STANDARD_DEVIATION 2.97 |
| International Index of Erectile Function (IIEF) - Total Sexual desire sub-score | 5.1 units on a scale STANDARD_DEVIATION 2.47 | 7.4 units on a scale STANDARD_DEVIATION 2.7 | 5.4 units on a scale STANDARD_DEVIATION 2.59 |
| International Index of Erectile Function (IIEF) - Total Total IIEF | 29.5 units on a scale STANDARD_DEVIATION 20.71 | 48.6 units on a scale STANDARD_DEVIATION 24.73 | 31.8 units on a scale STANDARD_DEVIATION 21.89 |
| International Prostate Symptom Score (IPSS) | 22.2 units on a scale STANDARD_DEVIATION 5.25 | 24.6 units on a scale STANDARD_DEVIATION 5.59 | 22.4 units on a scale STANDARD_DEVIATION 5.3 |
| Peak Urine Flow Rate (Qmax reported as mL/s) | 6.6 mL/s STANDARD_DEVIATION 4.03 | 8.1 mL/s STANDARD_DEVIATION 3.98 | 6.7 mL/s STANDARD_DEVIATION 4.02 |
| Post Void Residual (PVR) | 170.6 mL STANDARD_DEVIATION 156.27 | 112.0 mL STANDARD_DEVIATION 165.35 | 163.7 mL STANDARD_DEVIATION 157.06 |
| Prostate Specific Antigen (PSA) (ng/mL) | 3.9 ng/mL STANDARD_DEVIATION 2.71 | 5.5 ng/mL STANDARD_DEVIATION 6.71 | 4.1 ng/mL STANDARD_DEVIATION 3.37 |
| Prostate volume (g) | 66.4 g STANDARD_DEVIATION 11.8 | 65.9 g STANDARD_DEVIATION 14.71 | 66.4 g STANDARD_DEVIATION 12.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 7 Participants | 54 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 52 Participants | 7 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 6 |
| other Total, other adverse events | 40 / 52 | 5 / 6 |
| serious Total, serious adverse events | 6 / 52 | 1 / 6 |
Outcome results
Primary
International Prostate Symptom Score (IPSS) - Total Score at 12 Months
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months.
Time frame: 12 months
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | International Prostate Symptom Score (IPSS) - Total Score at 12 Months | 10.7 total score on a scale | Standard Deviation 8.8 |
| Transurethral Resection of the Prostate (TURP) | International Prostate Symptom Score (IPSS) - Total Score at 12 Months | 4.3 total score on a scale | Standard Deviation 5.9 |
Secondary
Duration of Hospitalization Post Procedure
The duration of hospitalization associated with the procedure will be calculated in hours. T
Time frame: 1 month
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Duration of Hospitalization Post Procedure | 23.1 hours | Standard Deviation 9.4 |
| Transurethral Resection of the Prostate (TURP) | Duration of Hospitalization Post Procedure | 32.2 hours | Standard Deviation 10.2 |
Secondary
Duration of Post Procedure Catheterization
The duration of post procedure catheterization will be calculated in hours.
Time frame: 1 month
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Duration of Post Procedure Catheterization | 24.2 hours | Standard Deviation 44.2 |
| Transurethral Resection of the Prostate (TURP) | Duration of Post Procedure Catheterization | 24.2 hours | Standard Deviation 12.9 |
Secondary
Number of Adverse Events Per Patient
Adverse events during the study were predominantly mild. There are over 4 times as many PAE patients as TURP, so the overall incidence rate of events is proportional to the size of the cohort represented. The most common events among patients who underwent embolization were transient dysuria, bladder spasm, hematuria, hematospermia, nausea and fever. The last 2 are typical of post embolic syndrome common to all embolization procedures. The most frequent adverse events for surgery patients were dysuria and hematuria. Events also include non-TEAEs.
Time frame: Through early termination of study (with less than 25% of subjects completing 12 month follow up)
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Number of Adverse Events Per Patient | Mild adverse events | 3.78 events per patient |
| Prostate Artery Emoblization (PAE) | Number of Adverse Events Per Patient | Moderate adverse events | 0.39 events per patient |
| Prostate Artery Emoblization (PAE) | Number of Adverse Events Per Patient | Severe adverse events | 0.21 events per patient |
| Transurethral Resection of the Prostate (TURP) | Number of Adverse Events Per Patient | Mild adverse events | 4.0 events per patient |
| Transurethral Resection of the Prostate (TURP) | Number of Adverse Events Per Patient | Moderate adverse events | 0.5 events per patient |
| Transurethral Resection of the Prostate (TURP) | Number of Adverse Events Per Patient | Severe adverse events | 0.17 events per patient |
Secondary
Number of Patients With Procedure Related Adverse Events
Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the case report form (CRF) which began prior to treatment will not be included in the summary tables but will be included in the AE data listings.
Time frame: TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up
Population: De Novo classification from FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization for symptomatic benign prostatic hyperplasia received 2017. IDE supplement proposed the termination of study follow-up visits; FDA granted approval of termination 03Nov2017. Early termination resulted in small numbers analyzed w less than 25% reaching 12 month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Cardiac disorders | 3 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Ear and labryinth disorders | 3 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Infections and infestation | 7 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Injury, poisoning and procedural complications | 3 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Investigations | 1 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Reproductive system and breast disorders | 13 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Surgical and medical procedures | 1 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Congenital, familial and genetic disorders | 1 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Metabolism and nutrition disorders | 2 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Musculoskeletal and connective tissue disorders | 10 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Nervous system disorders | 7 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Renal and urinary disorders | 30 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Endocrine disorders | 1 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Gastrointestinal disorders | 22 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | General disorders and administration site conditions | 11 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Respiratory, thoracic and mediastinal disorders | 4 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Skin and subcutaneous tissue disorders | 3 Participants |
| Prostate Artery Emoblization (PAE) | Number of Patients With Procedure Related Adverse Events | Vascular disorders | 4 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Reproductive system and breast disorders | 2 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Nervous system disorders | 1 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Ear and labryinth disorders | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Surgical and medical procedures | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Infections and infestation | 1 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Renal and urinary disorders | 5 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Injury, poisoning and procedural complications | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Respiratory, thoracic and mediastinal disorders | 2 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Endocrine disorders | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Vascular disorders | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Cardiac disorders | 1 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Gastrointestinal disorders | 2 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Congenital, familial and genetic disorders | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Investigations | 1 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Skin and subcutaneous tissue disorders | 2 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Metabolism and nutrition disorders | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | General disorders and administration site conditions | 0 Participants |
| Transurethral Resection of the Prostate (TURP) | Number of Patients With Procedure Related Adverse Events | Musculoskeletal and connective tissue disorders | 1 Participants |
Other Pre-specified
Free Prostate Specific Antigen (PSA) at 6 Month Follow up
Free PSA percentage summarized for both groups at 6 months follow up
Time frame: 6 month follow up
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Free Prostate Specific Antigen (PSA) at 6 Month Follow up | 18.7 percentage | Standard Deviation 8.7 |
| Transurethral Resection of the Prostate (TURP) | Free Prostate Specific Antigen (PSA) at 6 Month Follow up | 26.0 percentage | Standard Deviation 8.7 |
Other Pre-specified
International Index of Erectile Function (IIEF)
Erectile Function (Questions 1-5 & 15), score range 0-5, max score = 30 Orgasmic Function (Questions 9-10), score range 0-5, max score = 10 Sexual Desire (Questions 11-12), score range 1-5, max score = 10 Intercourse Satisfaction (Questions 6-8), score range 0-5, max score = 15 Overall Satisfaction (Questions 13-14), score range 1-5, max score = 10 SCORING for erectile dysfunction (Total of Q1-5 and Q15) is interpreted as follows: 1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction For all subscales, higher scores = less dysfunction/dissatisfaction Total IIEF is out of 75
Time frame: 6 months
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Emoblization (PAE) | International Index of Erectile Function (IIEF) | Overall satisfaction sub-score Q13-14 out of 10 points total | 5.4 score on a scale | Standard Deviation 3.1 |
| Prostate Artery Emoblization (PAE) | International Index of Erectile Function (IIEF) | Orgasmic function sub-score Q9-10 out of 10 points total) | 4.1 score on a scale | Standard Deviation 4 |
| Prostate Artery Emoblization (PAE) | International Index of Erectile Function (IIEF) | Sexual desire sub-score Q11-12 out of 10 points total | 5.9 score on a scale | Standard Deviation 2.4 |
| Prostate Artery Emoblization (PAE) | International Index of Erectile Function (IIEF) | Intercourse satisfaction sub-score Q6-8 out of 15 points total | 5.5 score on a scale | Standard Deviation 5.8 |
| Prostate Artery Emoblization (PAE) | International Index of Erectile Function (IIEF) | Total IIEF (Q1 to 15 out of 75 points total) | 33.3 score on a scale | Standard Deviation 24.4 |
| Prostate Artery Emoblization (PAE) | International Index of Erectile Function (IIEF) | Erectile function (sub-score Q1-5, 15 out of total 30pts) | 12.6 score on a scale | Standard Deviation 11.4 |
| Transurethral Resection of the Prostate (TURP) | International Index of Erectile Function (IIEF) | Total IIEF (Q1 to 15 out of 75 points total) | 61.7 score on a scale | Standard Deviation 25.3 |
| Transurethral Resection of the Prostate (TURP) | International Index of Erectile Function (IIEF) | Erectile function (sub-score Q1-5, 15 out of total 30pts) | 25.3 score on a scale | Standard Deviation 11.4 |
| Transurethral Resection of the Prostate (TURP) | International Index of Erectile Function (IIEF) | Overall satisfaction sub-score Q13-14 out of 10 points total | 8.7 score on a scale | Standard Deviation 3.3 |
| Transurethral Resection of the Prostate (TURP) | International Index of Erectile Function (IIEF) | Orgasmic function sub-score Q9-10 out of 10 points total) | 7.3 score on a scale | Standard Deviation 3.3 |
| Transurethral Resection of the Prostate (TURP) | International Index of Erectile Function (IIEF) | Intercourse satisfaction sub-score Q6-8 out of 15 points total | 11.7 score on a scale | Standard Deviation 5.8 |
| Transurethral Resection of the Prostate (TURP) | International Index of Erectile Function (IIEF) | Sexual desire sub-score Q11-12 out of 10 points total | 8.7 score on a scale | Standard Deviation 2.4 |
Other Pre-specified
Mean Prostate Volume, as Determined by MRI
The mean prostate volume as assessed by MRI is summarized at 3 month time point.
Time frame: 3 month follow-up
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Mean Prostate Volume, as Determined by MRI | 52.1 grams | Standard Deviation 15 |
| Transurethral Resection of the Prostate (TURP) | Mean Prostate Volume, as Determined by MRI | 28.2 grams | Standard Deviation 5.8 |
Other Pre-specified
Peak Urine Flow Rate (Qmax) at 1 Month
The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments was assessed at 1 month follow up. (Additional timepoints were not assessed due to early termination).
Time frame: 1 month follow-up
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Peak Urine Flow Rate (Qmax) at 1 Month | 12.1 mL/s | Standard Deviation 10.2 |
| Transurethral Resection of the Prostate (TURP) | Peak Urine Flow Rate (Qmax) at 1 Month | 14.0 mL/s | Standard Deviation 4.1 |
Other Pre-specified
Post-void Residual Urinary Volume (PVR)
The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments is summarized for both treatment groups at 1 month time point.
Time frame: 1 month follow-up
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Post-void Residual Urinary Volume (PVR) | 106 mL | Standard Deviation 136 |
| Transurethral Resection of the Prostate (TURP) | Post-void Residual Urinary Volume (PVR) | 7.5 mL | Standard Deviation 9.6 |
Other Pre-specified
Total Prostate Specific Antigen (PSA) at 6 Months
Prostate specific antigen (PSA) will be summarized for both treatment groups for 6 month time point
Time frame: 6 months
Population: Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prostate Artery Emoblization (PAE) | Total Prostate Specific Antigen (PSA) at 6 Months | 2.9 ng/mL | Standard Deviation 2 |
| Transurethral Resection of the Prostate (TURP) | Total Prostate Specific Antigen (PSA) at 6 Months | 2.1 ng/mL | Standard Deviation 1.1 |