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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03605745




Registration number
NCT03605745
Ethics application status
Date submitted
23/07/2018
Date registered
30/07/2018
Date last updated
11/05/2020

Titles & IDs
Public title
Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezum XL)
Scientific title
Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezum XL)
Secondary ID [1] 0 0
3034-001
Universal Trial Number (UTN)
Trial acronym
Rezum XL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BPH With Urinary Obstruction 0 0
BPH 0 0
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Prostatic Vapor Ablation

Experimental: Treatment - Prostatic Vapor Ablation with Rezum


Treatment: Devices: Prostatic Vapor Ablation
Rezum 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IPSS Improvement - 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.
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
Post Procedure Device Related Serious Complications - Demonstration that the composite rate of post procedure device related serious complications in treated subjects is statistically significantly less than 12% at 6 months.
Timepoint [2] 0 0
6 Months
Secondary outcome [1] 0 0
Device-related retention catheterization rate - This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Timepoint [1] 0 0
6 Month
Secondary outcome [2] 0 0
Absolute IPSS improvement at 6 Months
Timepoint [2] 0 0
6 Months
Secondary outcome [3] 0 0
Percent IPSS Responders at 1 year - The endpoint is defined as the same as the primary objective, but will be evaluated at 1 year of follow-up.
Timepoint [3] 0 0
1 Year
Secondary outcome [4] 0 0
Percent IPSS Responders at 2 years - The endpoint is defined as the same as the primary objective, but will be evaluated at 2 years of follow-up.
Timepoint [4] 0 0
2 Years
Secondary outcome [5] 0 0
Percent IPSS Responders at 3 years - The endpoint is defined as the same as the primary objective, but will be evaluated at 3 years of follow-up.
Timepoint [5] 0 0
3 Years

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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 Rezum 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Adventist Hospital/University of Sydney - Wahroonga
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the
Rezum System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and =150
cm3.
Trial website
https://clinicaltrials.gov/show/NCT03605745
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Woo, MD
Address 0 0
Sydney Adventist Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications