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

NCT ID: NCT03605745

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2020-08-11

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Prostatic Vapor Ablation with Rezum

Group Type: EXPERIMENTAL

Prostatic Vapor Ablation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Rezum; Water Vapor Ablation

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Woo, MD

Role: PRINCIPAL_INVESTIGATOR

Sydney Adventist Hospital

Locations

Arizona Urology Specialists

Scottsdale, Arizona, United States

Pinellas Urology, LLC

St. Petersburg, Florida, United States

First Urology, PSC

Jeffersonville, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Chesapeake Urology Associates, LLC

Towson, Maryland, United States

Adult & Pediatric Urology, P.C.

Omaha, Nebraska, United States

Jersey Urology Group

Somers Point, New Jersey, United States

Houston Metro Urology

Houston, Texas, United States

Urology San Antonio

San Antonio, Texas, United States

Sydney Adventist Hospital/University of Sydney

Wahroonga, New South Wales, Australia

Countries

United States; Australia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3034-001

Identifier Type: -

Identifier Source: org_study_id