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

Stopped early · Not applicable

Conditions studied: BPH With Urinary Obstruction, BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

In brief

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.

Key facts

Study ID

NCT03605745

Run by

Boston Scientific Corporation

People needed

47

Starts

2018-06-19

Expected to finish

2020-08-11

Last updated by the study team

2021-08-10

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 ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml.
• Post-void residual (PVR) ≤300 ml.
• Prostate volume >80 cm3 to ≤150 cm3

You may not qualify if…

• Urology:
• 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.
• Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery.
• Verified acute bacterial prostatitis within last 12 months documented by culture.
• Active or history of epididymitis within the past 3 months.
• Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device.
• 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.
• Subject interested in maintaining fertility.
• 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):
• Beta-blockers;
• Anticonvulsants;
• Antispasmodics;
• Antihistamines;
• Alpha blockers for BPH and anticholinergics or cholinergics;
• Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia));
• Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart));
• Estrogen, drug-producing androgen suppression, or anabolic steroids;
• PD5 Inhibitors (e.g., Viagra, Levitra or Cialis)
• 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
• Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment.
• Visible hematuria with subject urine sample without a known contributing factor.
• Presence of a penile implant or stent(s) in the urethra or prostate
• 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:
• Previous pelvic irradiation or radical pelvic surgery.

Where it is running

• 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

Full record on ClinicalTrials.gov

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