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

Completed · Not applicable

Conditions studied: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptom

In brief

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Key facts

Study ID

NCT01912339

Run by

Boston Scientific Corporation

People needed

197

Starts

2013-07-01

Expected to finish

2016-10-17

Last updated by the study team

2020-04-13

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
• Post-void residual (PVR) ≤250 ml.
• Prostate volume > 30 and ≤ 80 gm.

You may not qualify if…

• History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).
• 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.
• History of significant respiratory disease where hospitalization for the disease is required.
• History of immunosuppressive conditions (e.g., AIDS, post-transplant).
• Cardiac arrhythmias that are not controlled by medication or medical device.
• An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
• Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
• Presence of a penile implant or stent(s) in the urethra or prostate.
• Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate.
• 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.)).
• History of confirmed malignancy or cancer of prostate or bladder, however, high grade 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 randomization.
• Previous pelvic irradiation or radical pelvic surgery.
• Diagnosed with active Lyme Disease (borreliosis).
• 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.
• Has undergone prostate biopsy within 60 days prior to treatment date or has an imminent need for surgery.
• Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.
• 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.
• Verified bacterial prostatitis within last 12 months documented by culture or non-bacterial prostatitis within the last 5 years.
• Active or history of epididymitis within the past 3 months.
• Neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function.
• 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.
• Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the device.
• 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.
• Post-void residual (PVR) > 250 ml.

Where it is running

• Arizona Institute of Urology — Tucson, Arizona, United States
• Urology Associates of Denver — Denver, Colorado, United States
• South Florida Medical Research — Aventura, Florida, United States
• Southern Illinois University — Springfield, Illinois, United States
• Chesapeake Urology — Towson, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Metro Urology — Woodbury, Minnesota, United States
• Manhattan Medical Research — New York, New York, United States
• The Urology Group — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Texas Urology — Carrollton, Texas, United States
• UT Southwestern — Dallas, Texas, United States
• Urology of San Antonio — San Antonio, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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