Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate) (REZUM)
To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptom
Device: Rezum System
Procedure: Rigid Cystoscopy
|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)|
- 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.
- 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 ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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: Rigid Cystoscopy
Procedure: Rigid Cystoscopy
Endoscopy of the urinary bladder via the urethra.
Other Name: Cystoscopy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912339
|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|
|Townson, Maryland, United States, 21204|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|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, Ohio, United States, 44195|
|United States, South Carolina|
|Carolina Urologic Research Center|
|Myrtle Beach, South Carolina, United States, 29572|
|United States, Texas|
|Carrolton, Texas, United States, 75010|
|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|
|Principal Investigator:||Claus Roehrborn, MD||UT Southwestern|
|Principal Investigator:||Kevin McVary, MD||Southern Illinois University|