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

Primary Purpose

BPH With Urinary Obstruction, BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Prostatic Vapor Ablation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH With Urinary Obstruction focused on measuring BPH, Minimally Invasive, Water Vapor Therapy, Rezum

Eligibility Criteria

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

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.

Sites / Locations

  • Arizona Urology Specialists
  • Pinellas Urology, LLC
  • First Urology, PSC
  • University of Kansas Medical Center
  • Chesapeake Urology Associates, LLC
  • Adult & Pediatric Urology, P.C.
  • Jersey Urology Group
  • Houston Metro Urology
  • Urology San Antonio
  • Sydney Adventist Hospital/University of Sydney

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Prostatic Vapor Ablation with Rezum

Outcomes

Primary Outcome Measures

Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) > 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Number of Participants With Post Procedure Device Related Serious Complications
Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.

Secondary Outcome Measures

Number of Subjects With Device-related Retention Catheterizations
This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.

Full Information

First Posted
July 23, 2018
Last Updated
July 19, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03605745
Brief Title
Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)
Acronym
Rezūm XL
Official Title
Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decided to terminate the study due to business reasons
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH With Urinary Obstruction, BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords
BPH, Minimally Invasive, Water Vapor Therapy, Rezum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Prostatic Vapor Ablation with Rezum
Intervention Type
Device
Intervention Name(s)
Prostatic Vapor Ablation
Other Intervention Name(s)
Rezum, Water Vapor Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
Description
The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) > 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Time Frame
6 Months
Title
Number of Participants With Post Procedure Device Related Serious Complications
Description
Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of Subjects With Device-related Retention Catheterizations
Description
This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Time Frame
6 Month
Title
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
Description
The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male subjects ≥ 50 years of age who have symptomatic BPH. International Prostate Symptom Score (IPSS) score ≥ 13. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml. Post-void residual (PVR) ≤300 ml. Prostate volume >80 cm3 to ≤150 cm3 Exclusion Criteria: Urology: 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. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery. Verified acute bacterial prostatitis within last 12 months documented by culture. Active or history of epididymitis within the past 3 months. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device. 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. Subject interested in maintaining fertility. 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): Beta-blockers; Anticonvulsants; Antispasmodics; Antihistamines; Alpha blockers for BPH and anticholinergics or cholinergics; Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia)); Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)); Estrogen, drug-producing androgen suppression, or anabolic steroids; PD5 Inhibitors (e.g., Viagra, Levitra or Cialis) 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 Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment. Visible hematuria with subject urine sample without a known contributing factor. Presence of a penile implant or stent(s) in the urethra or prostate 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: Previous pelvic irradiation or radical pelvic surgery. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease. Nephrology: Compromised renal function defined as serum creatinine > 2.0 mg/dl. Hydronephrosis (Grade 2 or higher). Oncology: 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% History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial "PIN" is acceptable. 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: History of clinically significant congestive heart failure (i.e., NYHA Class III and IV). Cardiac arrhythmias that are not controlled by medication and/or medical device. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months. Pulmonology: History of significant respiratory disease where hospitalization for the disease is required. Hematology: Diagnosed or suspected bleeding disorder, or coagulopathies. Use of antiplatelet or anticoagulant medication except low dose aspirin (<100mg/day) within 10 days prior to treatment. Endocrinology: 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: History of immunosuppressive conditions (e.g., AIDS, post-transplant). Neurology: 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. 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: 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.). Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study. Inability to provide a legally effective "Informed Consent Form" and/or comply with all the required follow-up requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Woo, MD
Organizational Affiliation
Sydney Adventist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Urology Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Pinellas Urology, LLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
First Urology, PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Chesapeake Urology Associates, LLC
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Adult & Pediatric Urology, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Jersey Urology Group
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sydney Adventist Hospital/University of Sydney
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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