Clinical trial NCT03605745: Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (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
Overall status: TERMINATED
Phase: NA
Conditions: BPH With Urinary Obstruction
BPH
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords: BPH
Minimally Invasive
Water Vapor Therapy
Rezum
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 47
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
timeFrame: 6 Months
measure: Number of Participants With Post Procedure Device Related Serious Complications
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Subjects With Device-related Retention Catheterizations
timeFrame: 6 Month
measure: Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Saint Petersburg
country: United States
facility: Pinellas Urology, LLC
state: Florida
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Towson
country: United States
facility: Chesapeake Urology Associates, LLC
state: Maryland
city: Omaha
country: United States
facility: Adult & Pediatric Urology, P.C.
state: Nebraska
city: Somers Point
country: United States
facility: Jersey Urology Group
state: New Jersey
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital/University of Sydney
state: New South Wales
Study officials:
affiliation: Sydney Adventist Hospital
name: Henry Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: