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Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate) (REZUM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NxThera Inc
ClinicalTrials.gov Identifier:
NCT01912339
First received: July 26, 2013
Last updated: October 19, 2016
Last verified: October 2016
  Purpose
To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Condition Intervention
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptom
Device: Rezum System
Procedure: Rigid Cystoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezūm II)

Resource links provided by NLM:


Further study details as provided by NxThera Inc:

Primary Outcome Measures:
  • Efficacy: International Prostate Symptom Score (IPSS) [ Time Frame: 3 Month Follow-up Visit ] [ Designated as safety issue: No ]
    Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. The eighth question is designed to assess the degree of "bother" associated with the subject's urinary symptoms.

  • Safety: Device Related Serious Complications [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

    This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months.

    Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract.



Secondary Outcome Measures:
  • Percent Responders at 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Percent Responders at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Percent Responders at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: July 2013
Estimated Study Completion Date: June 2019
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment: Rezūm System
Device: Rezum System

The Rezūm System uses sterile water vapor (steam) to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland.

A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum.

A thin needle is deployed through the urethra into the transition zone, and a very short (8-10 second) treatment of water vapor is delivered directly into the hyperplastic tissue and immediately disperses through the tissue interstices.

Upon contact with the tissue, the vapor condenses, or phase shifts, into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone, gently and immediately denaturing the cell membranes, thereby causing instantaneous cell death.

Control
Control: Rigid Cystoscopy
Procedure: Rigid Cystoscopy
Endoscopy of the urinary bladder via the urethra.
Other Name: Cystoscopy

Detailed Description:
This study is a prospective, controlled, randomized single blind clinical trial of subjects with benign prostatic hyperplasia, which will allow for an interim analysis for sample size adjustment. Subjects first will be randomized in a 2:1 proportion in favor of the Treatment arm. Subjects in the Control arm will be allowed to crossover to have the Rezūm treatment after the 3-month follow-up examination.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
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 ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
  4. Post-void residual (PVR) ≤250 ml.
  5. Prostate volume > 30 and ≤ 80 gm.

Exclusion Criteria:

  1. History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).
  2. History of diabetes not controlled by a stable dose of medication over the past three months. Patients with a Hemoglobin A1c that is <8.0% are allowed.
  3. History of significant respiratory disease where hospitalization for the disease is required.
  4. History of immunosuppressive conditions (e.g., AIDS, post-transplant).
  5. Cardiac arrhythmias that are not controlled by medication or medical device.
  6. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
  7. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
  8. Presence of a penile implant or stent(s) in the urethra or prostate.
  9. Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate.
  10. Currently enrolled in any other pre-approval investigational study in the USA (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.)).
  11. History of confirmed malignancy or cancer of prostate or bladder, however, high grade PIN is acceptable.
  12. 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 randomization.
  13. Previous pelvic irradiation or radical pelvic surgery.
  14. Diagnosed with active Lyme Disease (borreliosis).
  15. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. 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.
  16. Has undergone prostate biopsy within 60 days prior to treatment date or has an imminent need for surgery.
  17. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.
  18. 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.
  19. Verified bacterial prostatitis within last 12 months documented by culture or non-bacterial prostatitis within the last 5 years.
  20. Active or history of epididymitis within the past 3 months.
  21. Neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function.
  22. 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.
  23. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the device.
  24. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months. Stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.
  25. Post-void residual (PVR) > 250 ml.
  26. Diagnosed or suspected bleeding disorder, or coagulopathies.
  27. Use of antiplatelet or anticoagulant medication except low dose aspirin (≤81 mg/day) within 10 days prior to treatment.
  28. Visible hematuria with subject urine sample without a known contributing factor.
  29. Subject interested in maintaining fertility.
  30. Use of beta-blockers, anticonvulsants, and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months).
  31. At the time of baseline assessment, in the absence of a qualifying exception, subjects who are using or have used the following medications, and are unable or unwilling to discontinue using these medications for the prescribed washout period:

    1. Use of antihistamines within 1 week of treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes).
    2. Use of the alpha blockers for BPH and anticholinergics or cholinergics (except for topical anti cholinergic eye drops), or within 4 weeks of baseline assessment.
    3. Use of Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) within 3 months of baseline assessment.
    4. Use of a dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) within 6 months of baseline assessment.
    5. Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment.
    6. Use of daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) within 4 weeks of baseline assessment.
  32. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter six months prior to baseline. A provoked episode now resolved is still admissible.
  33. Compromised renal function defined as serum creatinine > 2.0 mg/dl.
  34. Inability to provide a legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
  35. 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912339

Locations
United States, Arizona
Arizona Institute of Urology
Tucson, Arizona, United States, 85704
United States, Colorado
Urology Associates of Denver
Denver, Colorado, United States, 80113
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, Illinois
Southern Illinois University
Springfield, Illinois, United States, 62794
United States, Maryland
Chesapeake Urology
Townson, Maryland, United States, 21204
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Metro Urology
Woodbury, Minnesota, United States, 55125
United States, New York
Manhattan Medical Research
New York, New York, United States, 10016
United States, Ohio
The Urology Group
Cincinnati, Ohio, United States, 45212
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Texas Urology
Carrolton, Texas, United States, 75010
UT Southwestern
Dallas, Texas, United States, 75390
Urology of San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
NxThera Inc
Investigators
Principal Investigator: Claus Roehrborn, MD UT Southwestern
Principal Investigator: Kevin McVary, MD Southern Illinois University
  More Information

Responsible Party: NxThera Inc
ClinicalTrials.gov Identifier: NCT01912339     History of Changes
Other Study ID Numbers: 2105-001 
Study First Received: July 26, 2013
Last Updated: October 19, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by NxThera Inc:
Hyperlasia
Retention
Prostate

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016