A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
184
The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.
Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)
Urology Centers of Alabama
Birmingham, Alabama, United States
San Diego Clinical Trials
La Mesa, California, United States
Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
The primary safety endpoint is the proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment. Results are presented as a percentage rounded to the whole number.
Time frame: Three months post-treatment
Change Score of IPSS Questionnaire Between Baseline and 6 Months
The primary effectiveness endpoint is the IPSS change score from baseline to 6 months. International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.
Time frame: Six months post-treatment
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University of Southern California, Institute of Urology
Los Angeles, California, United States
Urology Associates, P.C.
Englewood, Colorado, United States
Adult & Pediatric Urology P.C.
Omaha, Nebraska, United States
Albany Medical College
Albany, New York, United States
Weill Cornell Medical College
New York, New York, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Metro Urology
Houston, Texas, United States
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