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Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (Rezūm XL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03605745
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3.

Condition or disease Intervention/treatment Phase
BPH With Urinary Obstruction BPH BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms Device: Prostatic Vapor Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: Treatment
Prostatic Vapor Ablation with Rezum
Device: Prostatic Vapor Ablation

Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.

Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.

Other Names:
  • Rezum
  • Water Vapor Ablation




Primary Outcome Measures :
  1. IPSS Improvement [ Time Frame: 6 Months ]
    The proportion of the intent-to-treat (ITT) analysis population that responds to therapy must be statistically significantly greater than 50%. A responder is defined as a subject who has an IPSS improvement > 30% post-treatment compared to baseline.

  2. Post Procedure Device Related Serious Complications [ Time Frame: 6 Months ]
    Demonstration that the composite rate of post procedure device related serious complications in treated subjects is statistically significantly less than 12% at 6 months.


Secondary Outcome Measures :
  1. Device-related retention catheterization rate [ Time Frame: 6 Month ]
  2. Absolute IPSS improvement at 6 Months [ Time Frame: 6 Months ]
  3. Percent IPSS Responders at 1 year [ Time Frame: 1 Year ]
    The endpoint is defined as the same as the primary objective, but will be evaluated at 1 year of follow-up.

  4. Percent IPSS Responders at 2 years [ Time Frame: 2 Years ]
    The endpoint is defined as the same as the primary objective, but will be evaluated at 2 years of follow-up.

  5. Percent IPSS Responders at 3 years [ Time Frame: 3 Years ]
    The endpoint is defined as the same as the primary objective, but will be evaluated at 3 years of follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects ≥ 50 years of age who have symptomatic BPH.
  2. International Prostate Symptom Score (IPSS) score ≥ 13.
  3. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml.
  4. Post-void residual (PVR) ≤300 ml.
  5. Prostate volume >80 cm3 to ≤150 cm3

Exclusion Criteria:

Urology:

  1. Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate.
  2. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery.
  3. Verified acute bacterial prostatitis within last 12 months documented by culture.
  4. Active or history of epididymitis within the past 3 months.
  5. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device.
  6. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.
  7. Subject interested in maintaining fertility.
  8. Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months):

    1. Beta-blockers;
    2. Anticonvulsants;
    3. Antispasmodics;
    4. Antihistamines;
    5. Alpha blockers for BPH and anticholinergics or cholinergics;
    6. Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia));
    7. Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart));
    8. Estrogen, drug-producing androgen suppression, or anabolic steroids;
    9. PD5 Inhibitors (e.g., Viagra, Levitra or Cialis)
  9. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter 6 months prior to baseline. A provoked episode now resolved is still admissible
  10. Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment.
  11. Visible hematuria with subject urine sample without a known contributing factor.
  12. Presence of a penile implant or stent(s) in the urethra or prostate
  13. Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months.

    Gastroenterology:

  14. Previous pelvic irradiation or radical pelvic surgery.
  15. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.

    Nephrology:

  16. Compromised renal function defined as serum creatinine > 2.0 mg/dl.
  17. Hydronephrosis (Grade 2 or higher).

    Oncology:

  18. Prostate cancer testing:

    If PSA is > 2.5 ng/ml and ≤ 10 ng/ml with free PSA <25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment

    • Males 50-59 years - PSA is >2.5 ng/ml and ≤10 ng/ml with free PSA <25%,
    • Males 60+ years - PSA is >4 ng/ml and ≤10 ng/ml, with free PSA <25%
  19. History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial "PIN" is acceptable.
  20. History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of enrollment.

    Cardiology:

  21. History of clinically significant congestive heart failure (i.e., NYHA Class III and IV).
  22. Cardiac arrhythmias that are not controlled by medication and/or medical device.
  23. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.

    Pulmonology:

  24. History of significant respiratory disease where hospitalization for the disease is required.

    Hematology:

  25. Diagnosed or suspected bleeding disorder, or coagulopathies.
  26. Use of antiplatelet or anticoagulant medication except low dose aspirin (<100mg/day) within 10 days prior to treatment.

    Endocrinology:

  27. History of diabetes not controlled by a stable dose of medication over the past three months, provided that patients with a hemoglobin A1c <8.0% are allowed.

    Immunology:

  28. History of immunosuppressive conditions (e.g., AIDS, post-transplant).

    Neurology:

  29. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires.
  30. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function (< 25% of accepted and established nomograms).

    General:

  31. Currently enrolled in any other pre-approval investigational study in the US (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).
  32. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
  33. Inability to provide a legally effective "Informed Consent Form" and/or comply with all the required follow-up requirements.

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): NCT03605745


Locations
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United States, Arizona
Arizona Urology Specialists
Scottsdale, Arizona, United States, 85258
United States, Florida
Pinellas Urology, LLC
Saint Petersburg, Florida, United States, 33710
United States, Indiana
First Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
Chesapeake Urology Associates, LLC
Towson, Maryland, United States, 21204
United States, Nebraska
Adult & Pediatric Urology, P.C.
Omaha, Nebraska, United States, 68114
United States, New Jersey
Jersey Urology Group
Somers Point, New Jersey, United States, 08244
United States, Texas
Houston Metro Urology
Houston, Texas, United States, 77030
Urology San Antonio
San Antonio, Texas, United States, 78229
Australia, New South Wales
Sydney Adventist Hospital/University of Sydney
Wahroonga, New South Wales, Australia, 2076
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Henry Woo, MD Sydney Adventist Hospital

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03605745    
Other Study ID Numbers: 3034-001
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Boston Scientific Corporation:
BPH
Minimally Invasive
Water Vapor Therapy
Rezum
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms