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Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia

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ClinicalTrials.gov Identifier: NCT01789840
Recruitment Status : Terminated (510(K) Approval Gained for Product)
First Posted : February 12, 2013
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

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).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Embosphere Microspheres Procedure: TURP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prostate artery emoblization (PAE)
Prostate artery embolization using Embosphere Microspheres
Device: Embosphere Microspheres
Active Comparator: Transurethral resection of the prostate (TURP)
Transurethral Resection of the Prostate (TURP)
Procedure: TURP
Other Name: TURP - Transurethal resection of the prostate




Primary Outcome Measures :
  1. IPSS Score [ Time Frame: 12 months ]
    The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post procedure.


Secondary Outcome Measures :
  1. Duration of hospitalization post procedure [ Time Frame: 1 month ]
    The duration of hospitalization associated with the procedure will be calculated in hours.The difference in treatment means will be calculated, including the corresponding 95% confidence interval, and treatment groups will be compared using Student's t-test for the ITT and Evaluable populations. If the distribution of the data is found to differ substantially from normal, appropriate methods will be used to analyze the data, including a data transformation or time to event analysis.

  2. Duration of post procedure catheterization [ Time Frame: 1 month ]
    The duration of post procedure catheterization will be calculated in hours. The difference in treatment means will be calculated, including the corresponding 95% confidence interval and treatment groups will be compared using Student's t-test for the ITT and Evaluable populations. If the distribution of the data is found to differ substantially from normal, appropriate methods will be used to analyze the data, including a data transformation or time to event analysis.

  3. Overall adverse events [ Time Frame: 12 months ]
    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 CRF which began prior to treatment will not be included in the summary tables but will be included in the AE data listings.

  4. Procedure related adverse events [ Time Frame: 12 months ]
    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 CRF which began prior to treatment will not be included in the summary tables but will be included in the AE data listings.


Other Outcome Measures:
  1. Change from baseline in peak urine flow rate (Qmax) [ Time Frame: 12 months ]
    The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments will be summarized for both treatment groups for the baseline and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.

  2. Change from baseline in erectile function using the International Index of Erectile Function (IIEF) [ Time Frame: 12 months ]

    Each subscale will be summarized separately for both treatment groups for the baseline, 1 month, 3 month, 6 month, and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.

    • Erectile Function (items 1, 2, 3, 4, 5, 15)
    • Orgasmic Function (items 9, 10)
    • Sexual Desire (items 11, 12)
    • Intercourse Satisfaction (items 6, 7, 8)
    • Overall Satisfaction (items 13, 14)

  3. Change from baseline in mean prostate volume, as determine by MRI [ Time Frame: 12 months ]
    The mean prostate volume as assessed by MRI will be summarized for both treatment groups for the baseline, 3 month and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.

  4. Change from baseline in post-void residual urinary volume (PVR) [ Time Frame: 12 months ]
    The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments will be summarized for both treatment groups for the baseline and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.

  5. Change in baseline from prostate specific antigen (PSA) [ Time Frame: 12 months ]
    Prostate specific antigen (PSA) will be summarized for both treatment groups for the baseline, 1 month, 3 month, 6 month, and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.



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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789840


Locations
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United States, California
Long Beach VA
Long Beach, California, United States, 90822
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Stanford University Medical Center
Stanford, California, United States, 94305
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Miami VA Healthcare System
Miami, Florida, United States, 33125
University of Miami Hospital
Miami, Florida, United States, 33136
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21207
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Merit Medical Systems, Inc.
Investigators
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Principal Investigator: Francisco Cesar Carnevale, PhD University of Sao Paolo, Brazil
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Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01789840    
Other Study ID Numbers: BPH-P3-12-01
2012-003446-33 ( EudraCT Number )
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Merit Medical Systems, Inc.:
BPH
Prostate
Prostatic Hyperplasia
enlarged prostate
LUTS
urinary retention
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases